Methods and apparatus for respiratory treatment

ABSTRACT

Apparatus and methods provide control for generation of a flow of air to a patient&#39;s airways for different respiratory therapies. The pressure and a flow rate may be simultaneously controlled so as to provide a pressure therapy and a flow therapy. The system may include one or more flow generators, in which the control of the pressure and flow rate may include altering the output of one or more of the flow generators and/or an optional adjustable vent. The pressure and flow rate may each be held at a constant. One or both of the pressure and flow rate may also vary in accordance with a desired therapy. The air may be provided via a patient interface that includes a vent to atmosphere, which may be the adjustable vent. The vent may be actuated by a controller to implement the simultaneous control of pressure and flow rate of the air.

1 CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/781,599, filed on Jun. 5, 2018, which is a national phase entry under35 U.S.C. § 371 of International Application No. PCT/AU2016/051210,filed Dec. 9, 2016, published in English, which claims priority fromU.S. Provisional Application No. 62/265,700, filed Dec. 10, 2015, all ofwhich are incorporated herein by reference.

2 STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

3 SEQUENCE LISTING

Not Applicable

4 BACKGROUND OF THE INVENTION 4.1 Field of the Invention

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. In particular, the present technology relates to medicaldevices or apparatus, and their use and may include devices fordirecting treatment gas to a patient's respiratory system.

4.2 Description of the Related Art

4.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2011.

A range of respiratory disorders exist.

Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing(SDB), is characterized by occlusion or obstruction of the upper airpassage during sleep. It results from a combination of an abnormallysmall upper airway and the normal loss of muscle tone in the region ofthe tongue, soft palate and posterior oropharyngeal wall during sleep.The condition causes the affected patient to stop breathing for periodstypically of 30 to 120 seconds duration, sometimes 200 to 300 times pernight. It often causes excessive daytime somnolence, and it may causecardiovascular disease and brain damage. The syndrome is a commondisorder, particularly in middle aged overweight males, although aperson affected may have no awareness of the problem. See U.S. Pat. No.4,944,310 (Sullivan).

Cheyne-Stokes Respiration (CSR) is a disorder of a patient's respiratorycontroller in which there are rhythmic alternating periods of waxing andwaning ventilation, causing repetitive de-oxygenation and re-oxygenationof the arterial blood. It is possible that CSR is harmful because of therepetitive hypoxia. In some patients CSR is associated with repetitivearousal from sleep, which causes severe sleep disruption, increasedsympathetic activity, and increased afterload. See U.S. Pat. No.6,532,959 (Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS) is defined as the combination ofsevere obesity and awake chronic hypercapnia, in the absence of otherknown causes for hypoventilation. Symptoms include dyspnea, morningheadache and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a groupof lower airway diseases that have certain characteristics in common.These include increased resistance to air movement, extended expiratoryphase of respiration, and loss of the normal elasticity of the lung.Examples of COPD are emphysema and chronic bronchitis. COPD is caused bychronic tobacco smoking (primary risk factor), occupational exposures,air pollution and genetic factors. Symptoms include: dyspnea onexertion, chronic cough and sputum production.

Neuromuscular Disease (NMD) is a broad term that encompasses manydiseases and ailments that impair the functioning of the muscles eitherdirectly via intrinsic muscle pathology, or indirectly via nervepathology. Some NMD patients are characterised by progressive muscularimpairment leading to loss of ambulation, being wheelchair-bound,swallowing difficulties, respiratory muscle weakness and, eventually,death from respiratory failure. Neuromuscular disorders can be dividedinto rapidly progressive and slowly progressive: (i) Rapidly progressivedisorders: Characterised by muscle impairment that worsens over monthsand results in death within a few years (e.g. Amyotrophic lateralsclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers);(ii) Variable or slowly progressive disorders: Characterised by muscleimpairment that worsens over years and only mildly reduces lifeexpectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic musculardystrophy). Symptoms of respiratory failure in NMD include: increasinggeneralised weakness, dysphagia, dyspnea on exertion and at rest,fatigue, sleepiness, morning headache, and difficulties withconcentration and mood changes.

Chest wall disorders are a group of thoracic deformities that result ininefficient coupling between the respiratory muscles and the thoraciccage. The disorders are usually characterised by a restrictive defectand share the potential of long term hypercapnic respiratory failure.Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.Symptoms of respiratory failure include: dyspnea on exertion, peripheraloedema, orthopnea, repeated chest infections, morning headaches,fatigue, poor sleep quality and loss of appetite.

Otherwise healthy individuals may take advantage of systems and devicesto prevent respiratory disorders from arising.

4.2.2 Therapies

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been usedto treat Obstructive Sleep Apnea (OSA). The mechanism of action is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion by pushing the soft palate and tongueforward and away from the posterior oropharyngeal wall.

Non-invasive ventilation (MV) provides ventilatory support (pressuresupport) to a patient through the upper airways to assist the patient intaking a full breath and/or maintain adequate oxygen levels in the bodyby doing some or all of the work of breathing (e.g., mechanical work ofbreathing). The ventilatory support is provided via a patient interface.NIV has been used to treat CSR, OHS, COPD, MD and Chest Wall disorders.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and may be providedusing a tracheostomy tube.

High Flow therapy (HFT) is the provision of a continuous, heated,humidified flow of air to an entrance to the airway through an unsealedor open interface at flow rates similar to, or greater than peakinspiratory flow. HFT has been used to treat OSA, CSR, COPD and otherrespiratory disorders. One mechanism of action is that the high flowrate of air at the airway entrance improves ventilation efficiency byflushing, or washing out, expired CO₂ from the patient's anatomicaldeadspace. HFT is thus sometimes referred to as a deadspace therapy(DST).

Another form of flow therapy is supplemental oxygen therapy, whereby airwith an elevated percentage of oxygen is supplied to an entrance to theairway through an unsealed interface.

4.2.3 Systems

One known device used for treating sleep disordered breathing is the S9Sleep Therapy System, manufactured by ResMed. Ventilators such as theResMed Stellar™ Series of Adult and Paediatric Ventilators may providesupport for invasive and non-invasive non-dependent ventilation for arange of patients for treating a number of conditions such as but notlimited to NMD, OHS and COPD.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit.

A treatment system may comprise a Positive Airway Pressure (PAP)device/ventilator, an air circuit, a humidifier, a patient interface,and data management.

4.2.4 Patient Interface

A patient interface may be used to interface respiratory equipment toits user, for example by providing a flow of air. The flow of air may beprovided via a mask to the nose and/or mouth, a tube to the mouth or atracheostomy tube to the trachea of the user. Depending upon the therapyto be applied, the patient interface may form a seal, e.g. with a faceregion of the patient, to facilitate the delivery of gas at a pressureat sufficient variance with ambient pressure to effect therapy, e.g. apositive pressure of about 10 cm H₂O. For other forms of therapy, suchas HFT, the patient interface may not include a seal sufficient tofacilitate delivery to the airways of a supply of gas at a positivepressure of about 10 cm H₂O.

4.2.5 Respiratory Apparatus (PAP Device/Ventilator)

Examples of respiratory apparatuses include ResMed's S9 AutoSet™ PAPdevice and ResMed's Stellar™ 150 ventilator. Respiratory apparatusestypically comprise a pressure generator, such as a motor-driven bloweror a compressed gas reservoir, and are configured to supply a flow ofair to the airway of a patient, typically via a patient interface suchas those described above. In some cases, the flow of air may be suppliedto the airway of the patient at positive pressure. The outlet of therespiratory apparatus is connected via an air circuit to a patientinterface such as those described above.

4.2.6 Humidifier

Delivery of a flow of air without humidification may cause drying ofairways. Medical humidifiers are used to increase humidity and/ortemperature of the flow of air in relation to ambient air when required,typically where the patient may be asleep or resting (e.g. at ahospital). As a result, a medical humidifier is preferably small forbedside placement, and it is preferably configured to only humidifyand/or heat the flow of air delivered to the patient without humidifyingand/or heating the patient's surroundings.

5 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the diagnosis, amelioration, treatment, or prevention ofrespiratory disorders having one or more of improved comfort, cost,efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe diagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to methods used in thediagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to the provision of adead space therapy comprising a controlled generation a flow of airtowards a patient's respiratory cavity for flushing expired gas (CO₂)from the patient's anatomical deadspace.

Another aspect of the present technology relates to the provision of apressure therapy comprising a controlled generation of pressurized airat a patient's respiratory system, (e.g., pressure support therapy tomechanically assist with patient respiration).

Another aspect of the present technology relates to methods of providingsuch a pressure therapy and such a dead space therapy simultaneously.

Another aspect of the present technology relates to apparatus configuredfor provision of such a pressure therapy and such a dead space therapysimultaneously or alternatively.

Some versions of the present technology may include a method forcontrolling a supply of air to a patient's airways for a respiratorytherapy. The method may include identifying, by one or more controllers,a predetermined pressure and a predetermined flow rate of the air to beprovided to a patient via a patient interface. The method may includedetermining, with a plurality of sensors, a pressure and a flow rate ofthe air being provided to the patient via the patient interface. Themethod may include controlling, by the one or more controllers, a firstflow generator and a second flow generator, each flow generator beingconfigured to provide a flow of the air to the patient interface, so asto simultaneously control the pressure and the flow rate of the air atthe patient interface to correspond with the predetermined pressure andthe predetermined flow rate, respectively.

In some method versions, the controlling the first flow generator andthe second flow generator may include adjusting output of at least oneof the first flow generator and the second flow generator. The patientinterface may include a projection portion configured to conduct a flowof the air into a naris of the patient and a mask portion configured toapply pressure of the air to the patient. The mask portion may be anasal mask. The mask portion may include nasal pillows. The method mayinclude detecting a continuous mouth leak, and reducing thepredetermined pressure upon detecting the continuous mouth leak. Thefirst flow generator may provide the flow of the air through theprojection portion of the patient interface and the second flowgenerator may apply pressure of the air to the mask portion of thepatient interface. At least one, or both, of the predetermined pressureand the predetermined flow rate may vary over a period of timecorresponding to a breathing cycle of the patient. The predeterminedflow rate may be constant for at least some predetermined period of timeand/or the predetermined pressure may be constant during thepredetermined period of time. The mask portion of the patient interfacefurther may include a vent.

In some versions, the method may include limiting the predetermined flowrate to be less than a maximum flow rate. The maximum flow rate may be avent flow rate minus a peak expiratory flow rate of the patient. Thesimultaneously controlling of the pressure and the flow rate may furtherinclude controlling an adjustment of the vent. The vent may include anactive proximal valve. The simultaneously controlling of the pressureand the flow rate may be performed so as to provide the patient with apositive airway pressure therapy and a deadspace therapy. The positiveairway pressure therapy may be a ventilation therapy. The method mayinclude determining, by the one or more controllers, the predeterminedpressure and the predetermined flow rate so as restrict thepredetermined pressure and the predetermined flow rate to a curve ofequal efficacy. The method may include calculating, in a controller ofthe one or more controllers, a target ventilation based on anatomicaldeadspace information and a deadspace therapy reduction value. Themethod may include generating, in a controller of the one or morecontrollers, a cardiac output estimate by controlling a step change inthe predetermined flow rate of the air and determining a change in ameasure of ventilation in relation to the step change. The method mayinclude initiating, by the controller of the one or more controllers,the controlling of the step change in the predetermined flow rate of theair in response to a detection of sleep.

Some versions of the present technology may include a system fordelivery of a flow of air to a patient's airways. The system may includea first flow generator and a second flow generator, each configured toprovide air to a patient via a patient interface. The system may includeone or more controllers. The one or more controllers may be configuredto determine a pressure and a flow rate of the air being provided to thepatient via the patient interface with a plurality of sensors. The oneor more controllers may be configured to control the first flowgenerator and the second flow generator so as to simultaneously controlthe pressure and the flow rate of the air at the patient interface tocorrespond with a predetermined pressure and a predetermined flow rate,respectively.

In some versions, the system may include the patient interface, whereinthe patient interface may include a projection portion configured toconduct a flow of the air into a naris of the patient and a mask portionconfigured to apply pressure of the air to the patient. The mask portionmay be a nasal mask. The mask portion may be nasal pillows. The firstflow generator may conduct the flow of the air through the projectionportion and the second flow generator may apply pressure of the air tothe mask portion. The plurality of sensors may include a flow ratesensor and a pressure sensor. An output of the first flow generator maybe measured by the flow rate sensor and an output of the second flowgenerator may be measured by the pressure sensor. The one or morecontrollers may be configured to maintain at least one of thepredetermined pressure and the predetermined flow rate at a constantvalue for at least some period of time. The one or more controllers maybe further configured to vary at least one of the predetermined pressureand the predetermined flow rate over a period of time corresponding to abreathing cycle of the patient. The mask portion of the patientinterface may include a vent. The one or more controllers may beconfigured to limit the predetermined flow rate to be less than amaximum flow rate. The one or more controllers may be configured todetermine the maximum flow rate by subtracting a peak expiratory flowrate of the patient from a vent flow rate. The vent may be an adjustablevent and the one or more controllers may be configured to control theadjustable vent so as to control the pressure and the flow rate. Theadjustable vent may include an active proximal valve. The simultaneouscontrol of the pressure and the flow rate of the air may provide thepatient with a positive airway pressure therapy and a deadspace therapy.The positive airway pressure therapy may be a ventilation therapy.

In some versions, the one or more controllers may be configured todetermine the predetermined pressure and the predetermined flow rate soas to restrict the predetermined pressure and the predetermined flowrate to a curve of equal efficacy. The one or more controllers mayinclude one controller configured to control the first flow generatorand the second flow generator. The one or more controllers may include afirst controller configured to control the first flow generator and asecond controller configured to control the second flow generator. Thefirst controller may be configured to obtain the flow rate of the airbeing provided by the second flow generator. The second controller maybe configured to obtain the pressure of the air being provided by thefirst flow generator. In some cases, a controller of the one or morecontrollers may be configured to compute a target ventilation based onanatomical deadspace information and a deadspace therapy reductionvalue. A controller of the one or more controllers may be configured togenerate a cardiac output estimate by controlling a step change in thepredetermined flow rate of the air and determining a change in a measureof ventilation in relation to the step change. The controller of the oneor more controllers may be configured to initiate control of the stepchange in the predetermined flow rate of the air in response to adetection of sleep.

Some versions of the present technology may include a system fordelivery of a flow of air to a patient's airways. The system may includea flow generator configured to provide air to a patient via an aircircuit and a patient interface. The system may include an adjustablevent. The system may include one or more controllers. The one or morecontrollers may be configured to determine a pressure and a flow rate ofthe air being provided to the patient via the patient interface with aplurality of sensors. The one or more controllers may be configured tocontrol the flow generator and the adjustable vent so as tosimultaneously control the pressure and the flow rate of the air at thepatient interface to correspond with a predetermined pressure and apredetermined flow rate, respectively.

In some versions, the system may include the patient interface. Thepatient interface may include a projection portion configured to conducta flow of the air into a naris of a patient and a mask portionconfigured to apply pressure of the air to the patient. The adjustablevent may be part of the mask portion of the patient interface. Theplurality of sensors may include a pressure sensor for determining ameasured pressure of the air. The plurality of sensors may include aflow rate sensor for determining a measured flow rate of the air throughthe projection portion of the patient interface. In some cases, at leastone of the pressure sensor and the flow rate sensor may be located at anoutput of the flow generator. In some cases, at least one of thepressure sensor and the flow rate sensor may be located at the patientinterface. The one or more controllers may be configured to maintain atleast one, or both, of the predetermined pressure and the predeterminedflow rate at a constant value for a period of time. The one or morecontrollers may be further configured to vary the predetermined pressurein accordance with a breathing cycle of the patient. The simultaneouscontrol of the pressure and the flow rate of the air may provide thepatient with a positive airway pressure therapy and a deadspace therapy.The positive airway pressure therapy may be a ventilation therapy. Theone or more controllers may be configured to determine the predeterminedpressure and the predetermined flow rate to restrict the predeterminedpressure and the predetermined flow rate to a curve of equal efficacy.

In some versions, the system may further include a variable resistancein the air circuit, wherein the one or more controllers may beconfigured to control one or more of the pressure and the flow rate ofthe air by adjusting the resistance of the variable resistance. In somecases, a controller of the one or more controllers may be configured tocompute a target ventilation based on anatomical deadspace informationand a deadspace therapy reduction value. A controller of the one or morecontrollers may be configured to generate a cardiac output estimate bycontrolling a step change in the predetermined flow rate of the air anddetermining a change in a measure of ventilation in relation to the stepchange. The controller of the one or more controllers may be configuredto initiate control of the step change in the predetermined flow rate ofthe air in response to a detection of sleep.

Some versions of the present technology may include a method forcontrolling a supply of air to a patient's airways for a respiratorytherapy. The method may include identifying, by one or more controllers,a predetermined pressure and a predetermined flow rate of the air to beprovided to a patient via an air circuit and a patient interface. Themethod may include determining, with a plurality of sensors, a pressureand a flow rate of the air being provided to the patient via the patientinterface. The method may include controlling, by the one or morecontrollers, a flow generator configured to provide the air to thepatient interface, and an adjustable vent so as to simultaneouslycontrol the pressure and the flow rate of the air at the patientinterface to correspond with the predetermined pressure and thepredetermined flow rate, respectively. The patient interface may includea projection portion configured to conduct a flow of the air into anaris of the patient and a mask portion configured to apply pressure ofthe air to the patient. The flow generator may provide the flow of theair through the projection portion of the patient interface therebyapplying pressure of the air to the mask portion of the patientinterface. The method may include maintaining, by the one or morecontrollers, at least one of the predetermined pressure and thepredetermined flow rate at a constant value for a period of time. Themethod may include varying, by the one or more controllers, thepredetermined pressure in accordance with a breathing cycle of thepatient. The simultaneous control of the pressure and the flow rate ofthe air may include control of a positive airway pressure therapy and adeadspace therapy. The positive airway pressure therapy may be aventilation therapy.

In some versions, the method may include determining, by the one or morecontrollers, the predetermined pressure and the predetermined flow rateso as to restrict the predetermined pressure and the predetermined flowrate to a curve of equal efficacy. The controlling of the adjustablevent comprises adjusting, by the one or more controllers, a ventingcharacteristic of the adjustable vent in synchrony with the patient'sbreathing cycle so as to maintain the pressure of the air at the patientinterface to correspond with the predetermined pressure. The method mayinclude adjusting, by the one or more controllers, a resistance of avariable resistance in the air circuit so as to control one or more ofthe pressure and the flow rate of the air. The method may includecalculating, in the one or more controllers, a target ventilation basedon anatomical deadspace information and a deadspace therapy reductionvalue. The method may include generating, in the one or morecontrollers, a cardiac output estimate by controlling a step change inthe predetermined flow rate of the air and determining a change in ameasure of ventilation in relation to the step change. The method mayinclude initiating, by the one or more controllers, the controlling ofthe step change in the predetermined flow rate of the air in response toa detection of sleep.

In yet another aspect of the present technology, a supply of air to apatient's airways may be controlled in connection with a respiratorytherapy. The respiratory therapy may include identifying, by one or morecontrollers, a predetermined pressure and a predetermined flow rate ofair to be provided to a patient via a patient interface; determining, byone or more sensors, a pressure and a flow rate of the air beingprovided to a patient via a patient interface; and controlling, by theone or more controllers, a first flow generator and a second flowgenerator, so as to simultaneously control the pressure and the flowrate of the air to correspond with the predetermined pressure and thepredetermined flow rate, respectively. Controlling the first flowgenerator and the second flow generator may include adjusting an outputof at least one of the first flow generator and the second flowgenerator. In addition, the patient interface may include a projectionportion configured to conduct a flow of the air into a naris of thepatient and a mask portion configured to apply pressure of the air tothe patient. The first flow generator may conduct the flow of the airthrough a projection portion of the patient interface and the secondflow generator may apply pressure from the air to a mask portion of thepatient interface.

In still another aspect, at least one of the predetermined pressure andthe predetermined flow rate may vary over a period of time correspondingto a breathing cycle of the patient. The predetermined flow rate mayalso be constant for at least some predetermined period of time and thepredetermined pressure may be constant during the predetermined periodof time.

In another aspect, the patient interface may include a vent, andsimultaneously controlling the pressure and the flow rate may includecontrolling an adjustment of the vent. The vent may include anadjustable proximal valve.

In still another aspect, simultaneously controlling the pressure and theflow rate may be performed so as to provide the patient with a pressuretherapy and a deadspace therapy.

In another aspect, a system for delivery of a flow of air to a patient'sairways may include a first flow generator and a second flow generatorfor providing air to a patient respiratory interface and one or morecontrollers configured to: determine a pressure and a flow rate of theair with a plurality of sensors, and control the first flow generatorand the second flow generator so as to simultaneously control thepressure and the flow rate of the air at the patient interface. Thepatient interface may include a projection portion configured to conducta flow of the air into a naris of the patient and a mask portionconfigured to apply pressure of the air to the patient. In addition, thefirst flow generator may conduct the flow of the air through theprojection portion and the second flow generator may apply air pressureto the mask portion. The plurality of sensors may include a flow sensorand a pressure sensor, and an output of the first flow generator may bemeasured by the flow sensor and an output of the first flow generatormay be measured by the pressure sensor. The controllers may beconfigured to maintain at least one of the pressure and the flow rate ata constant for at least some period of time. The controllers may also beconfigured so that at least one of the pressure and the flow rate isvariable over a period of time. The patient interface may include anadjustable vent and the one or more controllers may be furtherconfigured to control the adjustable vent.

In still another aspect, a system for delivery of a flow of air to apatient's airways may include a flow generator for providing air to apatient via a patient interface, an adjustable vent, and one or morecontrollers. The one or more controllers may be configured to determinea pressure and a flow rate of the air with one or more sensors andcontrol at least one of the flow generator and the adjustable vent so asto simultaneously control and vary the pressure and the flow rate of theair over a breathing cycle of the patient. The patient interface mayinclude a projection portion configured to conduct a flow of the airinto a naris of a patient and a mask portion configured to applypressure of the air to the patient. The adjustable vent may be a part ofthe mask portion of the patient interface. The system may also include apressure sensor for determining a measured pressure of the aircorresponding to the pressure of the air at the mask portion of thepatient interface and a flow sensor for determining a measured flow rateof the air through the projection portion of the patient interface. Atleast one of the pressure sensor and the flow sensor may be located atan output of the flow generator or at the patient interface. Inaddition, the controllers may be configured to vary the pressure inaccordance with a detected breathing cycle. The flow generator may alsoinclude a first flow generator and a second flow generator.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Also, various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

6 BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

6.1 Treatment Systems

FIG. 1A shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal pillows, receives a supply of airat positive pressure from a Combination Therapy (CT) device 4000. Airfrom the CT device is humidified in a humidifier 5000, and passes alongan air circuit 4170 to the patient 1000. A bed partner 1100 is alsoshown.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receives a supply of air atpositive pressure from a CT device 4000. Air from the CT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receives a supply ofair at positive pressure from a CT device 4000. Air from the CT deviceis humidified in a humidifier 5000, and passes along an air circuit 4170to the patient 1000.

6.2 Therapy

6.2.1 Respiratory System

FIG. 2 shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 3 shows a patient interface in the form of a nasal mask inaccordance with one form of the present technology.

6.3 Combination Therapy (CT) Device

FIG. 4A shows example components of a CT device in accordance with oneform of the present technology.

FIG. 4B shows a schematic diagram of either a pressure control or flowcontrol pneumatic circuit of a CT device in accordance with one form ofthe present technology. The directions of upstream and downstream areindicated.

FIG. 4C shows a schematic diagram of the electrical components of a CTdevice in accordance with one aspect of the present technology.

6.4 Humidifier

FIG. 5 shows an isometric view of a humidifier suitable for use with arespiratory apparatus.

6.5 Patient Interface

FIG. 6 shows a conventional nasal cannula;

FIG. 7 shows the nasal cannula of FIG. 6 in use with a mask;

FIG. 8 is an illustration of a nasal cannula with a coupler extension;

FIGS. 9A, 9B, 9C and 9D illustrate various cross sectional profiles forcoupler extensions of the present technology taken along line A-A ofFIG. 8;

FIG. 10A is an illustration of a nasal cannula with a coupler extensionin use with a mask;

FIG. 10B is an illustration of a nasal cannula with a coupler extensionin use with a mask showing a seat portion;

FIG. 11 is another illustration of a nasal cannula with a couplerextension having a seat ridge, the figure also includes a crosssectional view of the coupler extension taken along line A-A;

FIG. 12 is another illustration of a nasal cannula with a couplerextension FIG. 11 in use with a mask;

FIG. 13 is an illustration of another version of a nasal cannula with acoupler extension in use with a mask;

FIG. 14A is a plan view and a front elevation view of another examplecoupler extension for a nasal cannula of the present technology;

FIG. 14B is a front elevation view of another coupler extension for anasal cannula;

FIG. 14C is a front elevation view of another coupler extension for anasal cannula;

FIG. 15A is an illustration nasal interface of the present technologywith nasal projections;

FIG. 15B is an illustration of another nasal interface with nasalprojections;

FIG. 16 shows the nasal interface of FIG. 15A in use by a patient;

FIG. 17A and 17B show elevation and cross sectional views respectivelyof a further example nasal interface;

FIG. 18 is an illustration of a further nasal interface with a pillowvent;

FIG. 19A and 19B are illustrations of a further nasal interface withpillow vents in showing inspiratory flow and expiratory flowrespectively;

FIG. 20A and 20B are illustrations of a further nasal interface withvents showing expiratory and inspiratory operations respectively;

FIG. 20C and 20D are illustrations of a further nasal interface withvents showing expiratory and inspiratory operations respectively;

FIG. 20E and 20F are illustrations of a further nasal interface withvents showing expiratory and inspiratory operations respectively;

FIG. 21 is an illustration of a nasal pillow with a further examplenasal projection;

FIG. 22 is an illustration of a valve membrane of the example nasalprojection of FIG. 21;

FIGS. 23A and 23B show expiratory and inspiratory operationsrespectively of the valve membrane of the example nasal projection ofFIG. 21;

FIG. 24 illustrates an external side view of a mask frame with interfaceports for coupling with supply conduits;

FIG. 25A shows a plenum chamber or patient side of a mask frame for someversions of the present technology;

FIG. 25B shows another plenum chamber or patient side of a mask frame ofanother version of the present technology;

6.6 Combination Therapy System

FIG. 26 is an example schematic diagram of a combination therapy systemin accordance with some versions of the present technology;

FIG. 27 shows an electrical circuit model representing the flow of airin a combination therapy system in accordance with some versions of thepresent technology;

FIG. 28 is another example schematic diagram of a combination therapysystem in accordance with some versions of the present technology;

FIG. 29 is an example control methodology diagram for a combinationtherapy in accordance with some versions of the present technology;

FIG. 30 is a graph illustrating the relationship between interfacepressure and vent flow in one implementation of the present technology;

FIG. 31 is a graph illustrating the relationship between interfacepressure and vent flow in one implementation of the present technology;

FIG. 32 is a graph illustrating the additive or complementary nature ofcombination therapy according to the present technology; and

FIG. 33 shows an electrical circuit model representing the flow of airin a combination therapy system in accordance with anotherimplementation of the present technology.

7 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

7.1 Therapy

In one form, the present technology comprises a control method fortreating a respiratory disorder comprising controlling positive pressureto the entrance of the airways of a patient 1000 so as to providepressure therapy as well as controlling the flow rate of air to thepatient, so as to provide deadspace therapy, so as to allow foranatomical and/or apparatus deadspace flushing.

7.2 Treatment Systems

In one form, the present technology comprises an apparatus for treatinga respiratory disorder. The apparatus may comprise a CT device 4000 forsupplying pressurised air to the patient 1000 via an air circuit 4170 toa patient interface 3000.

7.3 Patient Interface

A non-invasive patient interface 3000 in accordance with one aspect ofthe present technology comprises the following functional aspects: aseal-forming structure 3100, a plenum chamber 3200, a positioning andstabilising structure 3300, a vent 3400, a decoupling structure 3500, aconnection port 3600 for connection to air circuit 4170, and a foreheadsupport 3700. In some forms a functional aspect may be provided by oneor more physical components. In some forms, one physical component mayprovide one or more functional aspects. In use the seal-formingstructure 3100 is arranged to surround an entrance to the airways of thepatient so as to facilitate the supply of air at positive pressure tothe airways.

An alternative non-invasive patient interface is an oro-nasal interface(full-face mask) that seals around both the nose and the mouth of thepatient 1000.

7.4 Combination Therapy (CT) Device

An example CT device 4000 in accordance with one aspect of the presenttechnology may comprise mechanical and pneumatic components 4100,electrical components 4200 and may be programmed to execute one or moretherapy algorithms. The CT device preferably has an external housing4010, preferably formed in two parts, an upper portion 4012 and a lowerportion 4014. Furthermore, the external housing 4010 may include one ormore panel(s) 4015. Preferably the CT device 4000 comprises a chassis4016 that supports one or more internal components of the CT device4000. In one form one, or a plurality of, pneumatic block(s) 4020 (e.g.,two) is supported by, or formed as part of the chassis 4016. The CTdevice 4000 may include a handle 4018.

The CT device 4000 may have one or more pneumatic paths depending on thetypes of patient interface coupled with the device. A pneumatic path ofthe CT device 4000 may comprise an inlet air filter 4112, an inletmuffler 4122, a pressure device 4140 capable of supplying air atpositive pressure (such as a blower 4142) and a flow device 4141 capableof supplying air at a desired or target flow rate (e.g., a blower oroxygen supply line etc.), one or more pneumatic blocks 4020 and anoutlet muffler 4124. One or more transducers 4270, such as pressuresensors or pressure transducers 4274 and flow rate sensors or flowtransducers 4272 may be included in the pneumatic path(s). Eachpneumatic block 4020 may comprise a portion of the pneumatic path thatis located within the external housing 4010 and may house eitherpressure device 4140 or flow device 4141.

The CT device 4000 may have an electrical power supply 4210, one or moreinput devices 4220, a central controller 4230, a therapy devicecontroller 4240, a pressure device 4140, flow device 4141, one or moreprotection circuits 4250, memory 4260, transducers 4270, datacommunication interface 4280 and one or more output devices 4290.Electrical components 4200 may be mounted on a single Printed CircuitBoard Assembly (PCBA) 4202. In an alternative form, the CT device 4000may include more than one PCBA 4202.

The CT device 4000 may be configured to control provision of any of thepressure and/or flow therapies described throughout this specification.

7.4.1 CT Device Mechanical & Pneumatic Components 4100

7.4.1.1 Air Filter(s) 4110

A CT device in accordance with one form of the present technology mayinclude an air filter 4110, or a plurality of air filters 4110 for eachpneumatic path.

In one form, an inlet air filter 4112 is located at the beginning of thepneumatic path upstream of a pressure device 4140. See FIG. 4B.

In one form, an outlet air filter 4114, for example an antibacterialfilter, is located between an outlet of the pneumatic block 4020 and apatient interface 3000. See FIG. 4B.

7.4.1.2 Muffler(s) 4120

In one form of the present technology, an inlet muffler 4122 is locatedin the pneumatic path upstream of a pressure device 4140. See FIG. 4B.

In one form of the present technology, an outlet muffler 4124 is locatedin the pneumatic path between the pressure device 4140 and a patientinterface 3000. See FIG. 4B.

7.4.1.3 Pressure Device 4140 and Flow Device 4141

In one form of the present technology, CT device 4000 may contain twoflow generators, such as a pressure device 4140 and a flow device 4141(see FIG. 4C). Pressure device 4140 may provide a supply of air atpositive pressure to a first portion of the patient interface 3000, andflow device 4141 may provide a flow of air to a second portion ofpatient interface 3000. Each flow generator may include a controllableblower 4142. For example the blower 4142 may include a brushless DCmotor 4144 with one or more impellers housed in a volute. The blower maybe preferably capable of delivering a supply of air, for example at arate of up to about 120 litres/minute, at a positive pressure in a rangefrom about 4 cm H₂O to about 20 cm H₂O, or in other forms up to about 30cm H₂O. The blower may include a blower as described in any one of thefollowing patents or patent applications the contents of which areincorporated herein in their entirety: U.S. Pat. Nos. 7,866,944;8,638,014, 8,636,479; and PCT patent application publication number WO2013/020167.

The pressure device 4140 and flow device 4141 may operate under thecontrol of the therapy device controller 4240. Alternatively, thepressure device 4140 and the flow device 4141 may operate under thecontrol of separate controllers.

In other forms, a pressure device 4140 or flow device 4141 may be apiston-driven pump, a pressure regulator connected to a high pressuresource (e.g. compressed air reservoir) or bellows.

7.4.1.4 Transducer(s) 4270

Transducers may be internal of the device, or external of the CT device.External transducers may be located for example on or form part of theair circuit, e.g. the patient interface. External transducers may be inthe form of non-contact sensors such as a Doppler radar movement sensorthat transmit or transfer data to the CT device.

In one form of the present technology, one or more transducers 4270 arelocated upstream and/or downstream of the pressure device 4140. The oneor more transducers 4270 may be constructed and arranged to measureproperties such as a flow rate, a pressure or a temperature at thatpoint in the pneumatic path.

In one form of the present technology, one or more transducers 4270 maybe located proximate to the patient interface 3000.

In one form, a signal from a transducer 4270 may be filtered, such as bylow-pass, high-pass or band-pass filtering.

7.4.1.4.1 Flow Transducer 4272

A flow transducer 4272 in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION.

In use, a signal representing a flow rate from the flow transducer 4272is received by the central controller 4230.

7.4.1.4.2 Pressure Transducer 4274

A pressure transducer 4274 in accordance with the present technology islocated in fluid communication with the pneumatic circuit. An example ofa suitable pressure transducer is a sensor from the HONEYWELL ASDXseries. An alternative suitable pressure transducer is a sensor from theNPA Series from GENERAL ELECTRIC.

In use, a signal from the pressure transducer 4274, is received by thecentral controller 4230.

7.4.1.4.3 Motor Speed Transducer 4276

In one form of the present technology a motor speed transducer 4276 isused to determine a rotational velocity of the motor 4144 and/or theblower 4142. A motor speed signal from the motor speed transducer 4276is preferably provided to the therapy device controller 4240. The motorspeed transducer 4276 may, for example, be a speed sensor, such as aHall effect sensor.

7.4.1.5 Anti-Spill Back Valve 4160

In one form of the present technology, an anti-spill back valve islocated between the humidifier 5000 and the pneumatic block 4020. Theanti-spill back valve is constructed and arranged to reduce the riskthat water will flow upstream from the humidifier 5000, for example tothe motor 4144.

7.4.1.6 Air Circuit 4170

An air circuit 4170 in accordance with an aspect of the presenttechnology is a conduit or a tube constructed and arranged in use toallow a flow of air to travel between two components such as thepneumatic block 4020 and the patient interface 3000.

In particular, the air circuit may be in fluid connection with theoutlet of the pneumatic block and the patient interface. The air circuitmay be referred to as air delivery tube. In some cases there may beseparate limbs of the circuit for inhalation and exhalation and/or formultiple patient interfaces. In other cases a single limb is used.

7.4.1.7 Oxygen Delivery 4180

In one form of the present technology, supplemental oxygen 4180 isdelivered to one or more points in the pneumatic path, such as upstreamof the pneumatic block 4020, to the air circuit 4170 and/or to thepatient interface 3000, such as via the nasal projections or prongs of acannula.

7.4.2 CT Device Electrical Components 4200

7.4.2.1 Power Supply 4210

A power supply 4210 may be located internal or external of the externalhousing 4010 of the CT device 4000.

In one form of the present technology power supply 4210 provideselectrical power to the CT device 4000 only. In another form of thepresent technology, power supply 4210 provides electrical power to bothCT device 4000 and humidifier 5000.

7.4.2.2 Input Devices 4220

In one form of the present technology, a CT device 4000 includes one ormore input devices 4220 in the form of buttons, switches or dials toallow a person to interact with the device. The buttons, switches ordials may be physical devices, or software devices accessible via atouch screen. The buttons, switches or dials may, in one form, bephysically connected to the external housing 4010, or may, in anotherform, be in wireless communication with a receiver that is in electricalconnection to the central controller 4230.

In one form the input device 4220 may be constructed and arranged toallow a person to select a value and/or a menu option.

7.4.2.3 Central Controller 4230

In one form of the present technology, the central controller 4230 isone or a plurality of processors suitable to control a CT device 4000.

Suitable processors may include an x86 INTEL processor, a processorbased on ARM Cortex-M processor from ARM Holdings such as an STM32series microcontroller from ST MICROELECTRONIC. In certain alternativeforms of the present technology, a 32-bit RISC CPU, such as an STR9series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPUsuch as a processor from the MSP430 family of microcontrollers,manufactured by TEXAS INSTRUMENTS may also be suitable.

In one form of the present technology, the central controller 4230 is adedicated electronic circuit.

In one form, the central controller 4230 is an application-specificintegrated circuit. In another form, the central controller 4230comprises discrete electronic components.

The central controller 4230 may be configured to receive input signal(s)from one or more transducers 4270, and one or more input devices 4220.

The central controller 4230 may be configured to provide outputsignal(s) to one or more of an output device 4290, a therapy devicecontroller 4240, a data communication interface 4280 and humidifiercontroller 5250.

In some forms of the present technology, the central controller 4230isconfigured to implement the one or more methodologies described hereinsuch as the one or more algorithms. In some cases, the centralcontroller 4230 may be integrated with a CT device 4000. However, insome forms of the present technology the central controller 4230 may beimplemented discretely from the flow generation components of the CTdevice 4000, such as for purpose of performing any of the methodologiesdescribed herein without directly controlling delivery of a respiratorytreatment. For example, the central controller 4230 may perform any ofthe methodologies described herein for purposes of determining controlsettings for a ventilator or other respiratory related events byanalysis of stored data such as from any of the sensors describedherein.

7.4.2.4 Clock 4232

Preferably CT device 4000 includes a clock 4232 that is connected to thecentral controller 4230.

7.4.2.5 Therapy Device Controller 4240

In one form of the present technology, therapy device controller 4240 isa pressure control module 4330 that forms part of the algorithmsexecuted by the central controller 4230. The therapy device controller4240 may be a flow control module that forms part of the algorithmsexecuted by the central controller 4230. In some examples it may be botha pressure control and flow control module.

In one form of the present technology, therapy device controller 4240may be one or more dedicated motor control integrated circuits. Forexample, in one form a MC33035 brushless DC motor controller,manufactured by ONSEMI is used.

7.4.2.6 Protection Circuits 4250

Preferably a CT device 4000 in accordance with the present technologycomprises one or more protection circuits 4250.

The one or more protection circuits 4250 in accordance with the presenttechnology may comprise an electrical protection circuit, a temperatureand/or pressure safety circuit.

7.4.2.7 Memory 4260

In accordance with one form of the present technology the CT device 4000includes memory 4260, preferably non-volatile memory. In some forms,memory 4260 may include battery powered static RAM. In some forms,memory 4260 may include volatile RAM.

Preferably memory 4260 is located on the PCBA 4202. Memory 4260 may bein the form of EEPROM, or NAND flash.

Additionally or alternatively, CT device 4000 includes removable form ofmemory 4260, for example a memory card made in accordance with theSecure Digital (SD) standard.

In one form of the present technology, the memory 4260 acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms.

7.4.2.8 Data Communication Systems 4280

In one preferred form of the present technology, a data communicationinterface 4280 is provided, and is connected to the central controller4230. Data communication interface 4280 is preferably connectable toremote external communication network 4282 and/or a local externalcommunication network 4284. Preferably remote external communicationnetwork 4282 is connectable to remote external device 4286. Preferablylocal external communication network 4284 is connectable to localexternal device 4288.

In one form, data communication interface 4280 is part of the centralcontroller 4230. In another form, data communication interface 4280 isseparate from the central controller 4230, and may comprise anintegrated circuit or a processor.

In one form, remote external communication network 4282 is the Internet.The data communication interface 4280 may use wired communication (e.g.via Ethernet, or optical fibre) or a wireless protocol (e.g. CDMA, GSM,LTE) to connect to the Internet.

In one form, local external communication network 4284 utilises one ormore communication standards, such as Bluetooth, or a consumer infraredprotocol.

In one form, remote external device 4286 is one or more computers, forexample a cluster of networked computers. In one form, remote externaldevice 4286 may be virtual computers, rather than physical computers. Ineither case, such remote external device 4286 may be accessible to anappropriately authorised person such as a clinician.

Preferably local external device 4288 is a personal computer, mobilephone, tablet or remote control.

7.4.2.9 Output Devices Including Optional Display, Alarms

An output device 4290 in accordance with the present technology may takethe form of one or more of a visual, audio and haptic unit. A visualdisplay may be a Liquid Crystal Display (LCD) or Light Emitting Diode(LED) display.

7.4.2.9.1 Display Priver 4292

A display driver 4292 receives as an input the characters, symbols, orimages intended for display on the display 4294, and converts them tocommands that cause the display 4294 to display those characters,symbols, or images.

7.4.2.9.2 Display 4294

A display 4294 is configured to visually display characters, symbols, orimages in response to commands received from the display driver 4292.For example, the display 4294 may be an eight-segment display, in whichcase the display driver 4292 converts each character or symbol, such asthe figure “0”, to eight logical signals indicating whether the eightrespective segments are to be activated to display a particularcharacter or symbol.

7.5 Humidifier

In one form of the present technology there is provided a humidifier5000 as shown in FIG. 5 to change the absolute humidity of air fordelivery to a patient relative to ambient air. Typically, the humidifier5000 is used to increase the absolute humidity and increase thetemperature of the flow of air relative to ambient air before deliveryto the patient's airways.

7.6 Combination Therapy Applications

As previously described, the patient interface 3000 and CT device 4000permit an application of various positive airway pressure (PAP)therapies, such as CPAP or bi-level PAP therapy or ventilation, or anyother pressure therapy mentioned in this specification. In addition, thedisclosed system may provide flow therapies, including deadspacetherapies, such as high flow therapy (“HFT”). In HFT, air may bedelivered to the nasal passages at a high flow rate, such as in therange of about 10 to about 35 litres/minute. A combination of thesetherapies may be provided to the patient using the disclosed technology,such as through providing a patient with a combination of pressuretherapy (e.g., CPAP) and deadspace therapy (e.g., HFT). The combinedflow and pressure therapies may be supplied by a common apparatus, suchas CT device 4000, or by separate apparatuses. In addition, changes in apatient's therapy may be applied with no or minimal changes to theconfiguration of patient interface on the patient.

For example, the CT device 4000 previously described may be coupled viaa delivery conduit (air circuit 4170) to the full-face mask 8008 (seee.g., FIG. 7) or via a delivery conduit (air circuit 4170) to the baseportion 16016 of the patient interface 16002 (see FIG. 15A), so as tocontrol pressure delivered to the mask or the chamber of each narispillow. In this way, a pressure therapy can be controlled by a pressurecontrol loop of a controller 4230 of the CT device 4000 so as to controla measure of interface pressure to meet a predetermined target pressure.The measure of interface pressure may be determined for example by apressure sensor. Such target pressures may be modified over time, suchas in synchrony with detected patient's respiration (e.g., Bi-leveltherapy or Pressure Support) or expected patient respiration (timedbackup breath). The seal of the mask or the naris pillows will permitthe pressure to be controlled at the entrance to the patient'srespiratory system.

In addition to the delivery of a controlled pressure to patientinterface 3000, a controlled flow of air may also be provided to thepatient via patient interface 3000. For example, supplemental oxygen maybe supplied by the one or more prongs 7004 a, 7004 b of the nasalcannula of FIGS. 6 and 7, or one or more of the nasal projections 16100of FIG. 15 or 17. By way of further example, HFT may be supplied to theone or more prongs 9004 a, 9004 b of the nasal cannula of, for example,FIG. 6, 7 or 8, or the nasal projections 16100 of the patient interfaceof FIG. 15 or 17 such as by a flow generator configured to provide HFT.In such a case, an additional flow generator or oxygen flow source maybe coupled by a projection conduit 17170 to the nasal projection or maybe coupled by one or more lumens 9012 to the prongs 9004. Optionally,the flow of gas to the prongs or nasal projections may be controlled bya flow control loop of a controller. For example, the flow can becontrolled by a flow control loop of a controller of the flow generatoror supplemental gas source so as to control a measure of flow rate ofair to meet a predetermined target flow rate. The measure of flow ratemay be determined for example by a flow rate sensor. The prongs of thecannula and/or nasal projections can permit a supply of air, such as athigh flow rates, within the patient's nasal passages.

In an alternative implementation, the controlled flow of air may bedelivered to the mouth via an oral interface such as that described inPCT Publication no. WO 2013/163685, the entire contents of which areherein incorporated by reference. The oral interface may be positionedwithin a full-face mask such as the mask 8008, or beneath a nasal masksuch as the mask 3000.

FIG. 26 illustrates a block diagram of an example CT device 4000 bywhich a controlled pressure and flow rate of air may be provided to apatient via patient interface 3000. As described above in connectionwith FIG. 4C, pressure device 4140 may be controlled by therapy devicecontroller 4240. The pressurized air from pressure device 4140 may betransmitted to patient interface 3000 via one or more pneumatic paths,such as air circuit 4170, which connects with patient interface 3000 atconnection port 3600. A pressure sensor 4274 may be configured tomeasure the pressure of the air associated with the air circuit 4170. Aflow rate sensor (not shown) may be configured to measure the flow rateof the air through air circuit 4170. In addition to pressure device4140, flow device 4141 may provide a flow of air to patient interface3000 via one or more pneumatic paths, such as projection conduit 17170.Projection conduit 17170 may connect to patient interface 3000 at one ormore secondary ports 19100. A flow rate sensor 4272 may be configured tomeasure the flow rate of the air through projection conduit 17170. Asset forth above, flow device 4141 may also be controlled by therapydevice controller 4240. Patient interface 3000 may also include a vent3400 to allow air to flow out of patient interface 3000 to atmosphere.

The flow rate of air that is provided to the patient at patientinterface 3000 will depend on the characteristics of vent 3400, whichmay be adjustable, as well as the pressure at patient interface 3000.For example, the flow rate of air out of vent 3400 may correspond withthe pressure at patient interface 3000. This correspondence may bequadratic in nature, in which the square of the flow rate out of vent3400 may approximately correspond to the air pressure in patientinterface 3000. Accordingly, the flow rate measured at flow rate sensor4272 will correspond to both the flow of air into the patient's airwaysas well as the flow of air through vent 3400. In addition, the flow ratemay also vary based on the configuration of other components, such asthe configuration of projection conduit 17170. Accordingly, in order toprovide the patient with a desired flow rate, therapy device controller4240 may calculate what the flow rate to the patient will be based onthe parameters of the system's various components. For example, therapydevice controller 4240 may access data from pressure sensor 4274 so asto calculate the flow rate out of vent 3400. Therapy device controller4240 may then compensate the flow rate measured at flow rate sensor 4272by the calculated flow rate out of vent 3400, so as to determine theeffective flow rate of air being provided to the patient. In addition,by controlling both the pressure and the flow rate of air into patientinterface 3000, CT device 4000 may control the deadspace flushing flowrate out of vent 3400.

In controlling the output of pressure device 4140 and flow device 4141,therapy device controller 4240 may simultaneously control the pressureand the flow rate of the air being provided to the patient via patientinterface 3000. In this way, the disclosed system may provide thepatient with a combination of respiratory therapies. For example,therapy device controller 4240 may control pressure device 4140 and flowdevice 4141 so that a patient is provided with CPAP therapy by having aconstant pressure at patient interface 3000, while also providing HFT ata constant flow rate via projection conduit 17170. Therapy devicecontroller 4240 may be configured so that the pressure and flow rate ofair are considered to be constant if the measured pressure and themeasured flow rate each remain within some predetermined thresholdrange.

In addition, therapy device controller 4240 may vary the pressure and/orthe flow rate of the air in accordance with a predetermined therapy. Forexample, the pressure device 4140 and flow device 4141 may be controlledso as to provide a bi-level pressure therapy or a CPAP therapy withexpiratory pressure relief in which the pressure of the air at patientinterface 3000 increases during a first period of time corresponding tothe patient's inspiration and decreases during a second period of timecorresponding to the patient's expiration. During these periods of timethe flow rate of the air may also be controlled so that the flow ratevaries by some predetermined amount in correspondence with the patient'sinspiration and expiration. In another example, the flow rate of the airmay be held constant while the pressure at patient interface 3000 isvaried.

Alternatively, the pressure may be held constant (e.g., CPAP), while theflow rate is varied. Pressure device 4140 and flow device 4141 may alsobe simultaneously controlled so that the pressure and flow rate of theair are both continuously varying over some period of time in accordancewith a therapy that calls for some predetermined, but varying, pressureand flow rate.

In another example, pressure device 4140 and flow device 4141 may alsobe simultaneously controlled so as to provide for auto-titrating CPAPtherapy (e.g., APAP) along with HFT. For example, a treatment pressuremay be increased upon detection of one or more Sleep DisorderedBreathing events. The flow rate of the HFT may be maintained relativelyconstant or similarly adjusted based on such detections. Accordingly, adeadspace therapy that would be otherwise compromised by OSA can be mademore effective through a pressure therapy, such as APAP, that opens thepatient's upper airways.

In yet another example, pressure device 4140 and flow device 4141 may becontrolled in a manner that allows for the patient to reach some targetamount of ventilation, such as by controlling pressure to providepressure support therapy. For example, the pressure device 4140 of thedisclosed CT system may implement adaptive servo-ventilation (ASV)therapy in combination with the high flow therapies described herein.Thus, the pressure may oscillate synchronously with patient's breathingcycle or with timed machine generated breaths to enforce a targetventilation. Similarly, the flow rate may be controlled to remainconstant or it may be controlled to vary such as as a function of thepatient's detected breathing cycle or as a function of the targetventilation.

By combining pressure and flow therapies, the disclosed system mayprovide the patient with a more effective overall therapy. For example,the effectiveness of an HFT therapy is diminished if the upper airway ofthe patient is closed. The patient's airway may be opened through theuse of various pressure therapies, such as a PAP treatment pressure(e.g., APAP or CPAP). Therefore, HFT therapy may be made to be moreeffective by being combined with a pressure therapy.

Pressure support or ventilation therapy reduces the work required fromthe patient for breathing by providing mechanical pressure support andmay allow for greater recovery of alveolar deadspace, as airways to thelungs are opened by the pressure support. Flow therapy, such as HFT,also reduces the work of breathing and allows for greater recovery ofanatomical deadspace by flushing carbon dioxide rich areas of thepatient's airways with air. A combination of pressure therapy and flowtherapy may also assist a patient in achieving sufficient positiveend-expiratory pressure (PEEP). In this way, a combination of a flowtherapy and a pressure therapy may allow a patient who experiencesinsufficient minute ventilation or alveolar ventilation to receive agreater volume of gas exchange within the patient's lungs through theremoval of anatomical and alveolar deadspace and the increase in tidalvolume that is being provided to the patient's lungs. In addition,simultaneous HFT may also allow pressure support therapy to beadministered at a lower level of pressure support, thereby improving theacceptability of the pressure support therapy. For example, excessivelevels of pressure support can induce lung injury. As another example,using pressure support to force air through bronchitis lung produceshigh flow velocity in the bronchial flow paths, which can causediscomfort and even further inflammation. As another example, pressuresupport therapy results in a cyclic acoustic noise pattern whose volumeincreases with the level of pressure support.

Accordingly, a combination of one or more pressure therapies with one ormore flow therapies, as described herein, may be additive orcomplementary. For example, FIG. 32 contains a graph 32000 illustratingthe possible effects of combination therapy on a hypercapnic patient(one with elevated PCO₂). The horizontal axis represents the flushingflow rate of the combination therapy and the vertical axis represents apressure support of a combination therapy in which the pressure therapyis a bi-level therapy. The point 32010 represents a therapy in which thepressure support is zero but the flushing flow rate is high, e.g. 100litres per minute. In such a case, the therapy can be considered asessentially just a deadspace therapy. The point 32020 represents atherapy in which the pressure support is high, e.g. 20 cm H₂O, but theflushing flow rate is zero. In such a case, the therapy can beconsidered as essentially just a pressure support therapy. The points32010 and 32020 represent forms of therapy which are equally effectiveby some measure, e.g. reducing the PCO₂ by 15%. Both however are“extreme” forms, i.e. involve high flushing flow rate and zero pressuresupport, or high pressure support and zero flushing flow raterespectively. All points along the curve 32030 may represent combinationtherapies that are as effective as the extreme therapies represented bythe points 32010 and 32020, but are more moderate in both pressuresupport and flushing flow rate than either of those extreme therapies.The present technology allows any point on the curve 32030, e.g. thepoint 32040, representing a combination therapy with moderate pressuresupport and flushing flow rate, to be chosen for a patient depending onthe preferences and characteristics of the patient, without altering theeffectiveness of the combination therapy. The curve 32030 may bereferred to as a curve of equal efficacy. In essence, the combinationtherapy may have a synergistic effect depending on settings that canprovide treatment as effective as either one of the individual therapiesbut at reduced levels so as to unexpectedly reduce the potential fornegative consequences that may be associated with higher levels of eachindividual therapy.

Accordingly, in some versions, controller(s) of apparatus for generatingsuch combination therapy may be configured with such a curve (e.g., datavalues or a programmed function in a memory representing such a curve)to regulate a synergistic control of the therapies. For example, if acondition is detected by the controller, a change in the combinationtherapy may be made by automatically varying the setting of each controlparameter (e.g., target pressure and target flow rate) so that they arerestricted to the curve. By way of further example, if a change is madeto the setting of a control parameter for one therapy (eitherautomatically or manually), the control parameter for the other therapymay be set or recommended by the controller according to such a curve tocomplement the change to the first control parameter. Thus, thecontroller(s) may be configured to vary a target pressure and/or atarget flow rate so as to restrict them to a predetermined curve ofequal efficacy.

In accordance with the presently disclosed technology, the combinationof a pressure therapy and a flow therapy may take a number of differentforms. For example, a constant pressure (e.g., CPAP) may be used incombination with either a variable or a constant flow rate. In anotherexample, the pressure therapy may provide a semi-fixed pressure that isadjusted in accordance with a patient's detected breathing events (e.g.,obstructive apnea, hypopnea, etc.). In particular, the pressure therapy(e.g. APAP) may be provided in accordance with an AutoSee™ pressure thatis automatically set by the pressure controller to a minimum pressureneeded to keep the patient's airways open. In yet another example, avariable pressure therapy (e.g., Expiratory Pressure Relief (EPR) orbi-level pressure, or servo-ventilation bi-level (pressure support)modes such as ASV, ASV Auto or iVAPS) may be used in combination with afixed or a variable flow rate. A variable pressure and variable flowrate may vary based on characteristics of the patient's breathing,thereby facilitating the breathing process.

The control of the flow of air between CT device 4000 and the patientmay be modelled as an electrical circuit 2700, as shown in FIG. 27. Thepositive airway pressure (PAP) device shown may be pressure device 4140described above, while the deadspace therapy (DST) device may be flowdevice 4141. The PAP device and the DST device may be incorporated intoa single housing such as the housing 4010 of a CT device 4000, or mayexist as separate units.

As shown in FIG. 27, air flows from the output of the PAP device at aflow rate Q1, and air flows from the output of the DST device at a flowrate Q2. The resistance R1 represents the resistance of air flow thatmay exist in the pneumatic path from the output of the PAP device to theplenum chamber 3200 of the patient interface 3000. For example, R1 mayinclude the resistance of air flow along air circuit 4170. Theresistance R2 represents the resistance of air flow that may exist inthe pneumatic path from the output of the DST device to the end of theprongs or projections. For example, R2 may include the resistance of airflow along projection conduit 17170. The resistance Rnose represents theresistance of air flow from the end of the prongs or projections withinthe patient's nose back out the nares to the plenum chamber 3200 of thepatient interface 3000. The flow whose flow rate is represented by Q2 isa flushing flow for both anatomical and mechanical deadspace (i.e.deadspace due to the patient interface), so Q2 is referred to as theflushing flow rate.

The pressure of the air at the output of the PAP device is representedas Pd. The pressure of the air at the end of the prongs or projectionswithin the patient's nose is represented as Pnose. The pressure Pmrepresents the air pressure within the plenum chamber 3200 of thepatient interface 3000. Air may flow out of the patient interface 3000through a fixed or adjustable vent, such as vent 3400. The flow ratethrough the vent is represented as Qvent. The vent flow rate Qvent maycorrespond to the interface pressure Pm. Accordingly, Qvent may berepresented as a function of Pm through the notation Qvent(Pm). The flowrate of air to the patient (the respiratory flow rate) is represented byQr, with the resistance of air flow through the patient's airways beingrepresented by Rairway. Air will flow in and out of the patient's lungsserving as an alternating pressure source during the patient's breathingcycle. Plungs is therefore shown as an alternating pressure source, withClungs representing the elastic response of the patient's lungs to theair flow being provided at the patient interface.

From the topology of the model 2700, it may be shown that the sum of thePAP and DST flow rates Q1 and Q2 is equal to the sum of the respiratoryflow rate Qr and the vent flow rate Qvent:

Q1+Q2=Qvent(Pm)+Qr

Because the average respiratory flow rate Qr over many breathing cyclesis zero, the average or DC component of the vent flow rate Qvent, whichmay be referred to as the “bias flow rate”, is the sum of the average orDC components of Q1 and Q2.

The PAP and DST devices of the model 2700 may be controlled so as tomanage both the pressure and flow rate of air in the system, which maybe achieved by control changes of the flow generators of the PAP and/orDST devices, and optionally in conjunction with controlling mechanicalvariations of the opening size of the vent. In general, the interfacepressure Pm and the deadspace flushing flow rate Q2 may be controlledindependently by respective control of the PAP and DST devices. Inparticular, the PAP device may maintain a given interface pressure Pm bysetting its own output pressure Pd to compensate for the known pressuredrop through the resistance R1 at any given flow rate Q1. However, inorder to maintain this control it is beneficial to maintain a positiveflow rate Q1 from the PAP device, to ensure the device pressure Pd isgreater than the interface pressure Pm. To keep Q1 positive, theflushing flow rate Q2 may be controlled so that throughout the patient'sbreathing cycle the following is true:

Q2<Qvent(Pm)+Qr

During expiration, the respiratory flow rate Qr is negative, so bycontrolling Q2 to be less than Qvent minus the peak expiratory flow rateQe(peak), Q1 may be kept positive throughout the breathing cycle. Inother words, the maximum flushing flow rate Q2(max) isQvent(Pm)-Qe(peak). Since in general a lower pressure Pm means a lowervent flow rate Qvent, a lower pressure Pm means a lower ceiling on theflushing flow rate Q2. As long as the flushing flow rate is less thanQ2(max), the positive flow Q1 from the PAP device makes up thedifference between Q2 and Qvent+Qr. Q1 therefore oscillates around asteady state value of Qvent−Q2 in synchrony with the breathing cycle,rising during inspiration and falling during expiration.

In this way, the desired flushing of deadspace, such as the flushing ofcarbon dioxide from the patient's anatomical deadspace, may beaccomplished through control of the vent pressure/flow characteristic.For example, for a given interface pressure Pm, an adjustment to thevent to allow a higher vent flow rate Qvent(Pm) allows a higherdeadspace flushing flow rate Q2.

The vent flow rate, Qvent, may approximate a quadratic relationship withthe patient interface pressure Pm, such that:

Pm=(A*Qvent ²)+(B*Qvent)

The terms “A” and “B” are values that may be based on one or moreparameters of the vent. These parameters may be adjusted so as to alterthe relationship between Qvent and Pm such as when the opening size ofan active proximal valve (APV) serving as the vent 3400 is controlled tochange. An example APV is disclosed in PCT Publication no. WO2010/141983, the entire disclosure of which is incorporated herein byreference.

For example, in some cases, changing treatment may require changing ofventing characteristics associated with the patient interface. Thus, insome cases, such as when a pressure therapy is being provided with thenaris pillows and a CT device, it may thereafter become desirable toinitiate a flow therapy with the nasal projections, such as providing aflow of supplemental oxygen or high flow therapy. This change intreatment, which may be processor activated in the case of a commonapparatus or manually initiated such as in the case of multiple supplydevices, may require an adjustment to a venting characteristic of thepatient interface. For example, a manual vent may be opened or openedmore so as to compensate for the increased flow of gas to the patient'snares. Alternatively, in the case of an adjustable vent, a processor maycontrol opening of the vent or opening it more upon activation of theadditional flow to the nasal projections. Similar vent control may beinitiated upon application of a mask over a cannula such as in theillustration of FIGS. 7, 10, 12 and 13. In the case of termination ofsuch an additional therapy, the venting characteristics may be changedagain, such as by manually closing or reducing a vent size or bycontrolling with a controller a closing or reduction in the vent size ofan automatic/electro-mechanical vent (e.g., an active proximal valve).

The therapy device controller 4240 may control the device pressure Pd ofthe pressure device 4140 to deliver a desired or target interfacepressure Pm such as for controlling a generally constant (with respectto breathing cycle) pressure therapy, without needing to know theflushing flow rate Q2 being delivered by the flow device 4141. In such acase, the therapy device controller 4240 may use conventional methods ofleak estimation and compensation. Under such an approach, the therapydevice controller 4240 may effectively treat the flushing flow as alarge, constant, negative leak flow that may be estimated andcompensated for such as when estimating patient flow and/or adjustingpressure to counter undesired pressure swings induced by patientrespiration. Similarly, to deliver a bi-level pressure therapy, thetherapy device controller 4240 may control the device pressure Pd of thepressure device 4140 to synchronise the mask pressure Pm with thepatient's breathing cycle without needing to know the flushing flow rateQ2. Under such an approach, the therapy device controller 4240 may useconventional leak estimation and compensation methods to estimate therespiratory flow rate Qr, effectively treating the flushing flow as alarge, constant, negative leak flow. The therapy device controller maythen apply conventional triggering and cycling processing to therespiratory flow rate Qr to determine when to switch the desiredinterface pressure Pm from inspiration to expiration and back.

However, it may be advantageous for the therapy device controller 4240to account explicitly for the flushing flow rate Q2 for either or bothof controlling the interface pressure Pm and estimating the respiratoryflow rate Qr for triggering and cycling purposes.

Likewise, it may be advantageous for the therapy device controller 4240to use the sensed device pressure Pd from the pressure sensor 4274 inorder to compute the interface pressure Pm and hence the maximumflushing flow rate Q2(max), namely Qvent(Pm)-Qe(peak), to ensure theflushing flow rate does not exceed this upper limit.

In implementations in which the pressure device 4140 and the flow device4141 are under the control of a common therapy device controller 4240,as in FIG. 26, the controller 4240 is aware of all the system variablessuch as the device pressure Pd and the flushing flow rate Q2 (such aswith sensed values for the variables), and can therefore control thepressure device 4140, the flow device 4141, and optionally an adjustablevent 3400 to deliver a desired interface pressure Pm and flushing flowrate Q2 in accordance with the above description.

However, in implementations in which the pressure device 4140 and theflow device 4141 are under the control of separate controllers, thepressure device controller may obtain the flushing flow rate Q2, eitherby direct communication with the flow rate transducer 4272, or throughcommunication with the flow device controller. Likewise, the flow devicecontroller may obtain the device pressure Pd either by directcommunication with the pressure transducer 4274, or throughcommunication with the pressure device controller.

7.6.1 Single Flow Generator Examples

In some implementations, a single flow generator may be used to supplyboth the flushing flow rate of gas through one or more of the nasalprojections or prongs and the air pressure within the patient interface3000. In one such implementation, the air circuit 4170 is not used, theconnection port 3600 is blocked, and projection conduit 17170 may beconnected to the output of a single blower 4142, as shown in FIG. 28. Insuch an implementation, which may be modelled by the circuit model 2700without the PAP device or the resistance R1, the flow rate Q1 isidentically zero, so for any given venting characteristic Qvent(Pm), thevent flow rate Qvent will oscillate in synchrony with the breathingcycle around the flushing flow rate Q2, rising to Q2+Qe at peakexpiration, and falling to Q2−Qi at peak inspiration, as illustrated inFIG. 30. The interface pressure Pm will also oscillate along the ventingcharacteristic around a steady state pressure Pm0 such that Qvent(Pm0)equals the flushing flow rate Q2, falling during inspiration to a troughpressure Pmi and rising during expiration to a peak pressure Pme. Suchoscillation in interface pressure may not be desirable and may beminimised by adjusting the venting characteristic in synchrony with thepatient's breathing cycle. For example, as illustrated in FIG. 31, tomaintain a constant interface pressure Pm0 at a given flushing flow rateQ2, the parameters of the venting characteristic may be continuallyadjusted in synchrony with the patient's breathing cycle so that theventing characteristic follows the curve VC-E during expiration, causingQvent(Pm0) to rise to Q2+Qe and follows the curve VC-I duringinspiration, causing Qvent(Pm0) to fall to Q2−Qi.

Similar continuous adjustments to the venting characteristic may also bemade to maintain a constant interface pressure Pm throughout thebreathing cycle in an implementation with no DST device, so that Q2 isidentically zero. In such an implementation, for any given PAP devicepressure Pd, resistance R1, venting characteristic Qvent(Pm), andrespiratory flow rate Qr, the interface pressure Pm satisfies theequation

Pd−Pm/R1=Qvent(Pm)+Qr

Continual adjustments to the venting characteristic, or to the devicepressure Pd, in synchrony with the breathing cycle allow Pm to bemaintained at its steady state value (i.e. its value when Qr is zero) asQr varies over the breathing cycle.

Accordingly, in such single-flow-generator implementations, theinterface pressure Pm and flushing flow rate Q2 may be simultaneouslyand independently controlled by varying one or more parameters of thevent 3400 so that a predetermined pressure and predetermined flushingflow rate are maintained at patient interface 3000 throughout thebreathing cycle. Further, this configuration allows for control of bothPm and Q2 to arbitrary patterns with respect to time and the patient'srespiration. For example, a bi-level pressure waveform for Pm where theinspiratory pressure is higher than the expiratory pressure while Q2 isalso controlled to vary based on aspects of the patient's breathing.Other examples include Pm of pressure therapy modes of CPAP, APAP, APAPwith EPR, ASV, ST, and iVAPS combined with a Q2 of flow therapy modessuch as fixed flow rate, flow rate varying on the patient's state ofinspiration or expiration, or other ventilation parameters such asrelative hyperventilation or hypoventilation with respect to theventilation mean.

In another single flow generator implementation in which there is noseparate DST device, the output of the PAP device is connected to boththe air circuit 4170 and the projection conduit 17170. Such animplementation may be modelled by the electrical circuit model 2700 aillustrated in FIG. 33. Independent control of the interface pressure Pmand the flushing flow rate Q2 to their respective target valuesthroughout the breathing cycle may be enabled by adjusting the ventcharacteristic in synchrony with the breathing cycle as described above.Alternatively, or additionally, independent control of the interfacepressure Pm and the flushing flow rate Q2 to their respective targetvalues throughout the breathing cycle may be enabled by adjusting thedevice pressure Pd in synchrony with the breathing cycle. Alternatively,or additionally, the resistance of the air circuit 4170 may be madevariable, e.g. by adding a variable resistance (e.g., a proportionalvalve) in the air circuit 4170. Independent control of the interfacepressure Pm and the flushing flow rate Q2 to their respective targetvalues throughout the breathing cycle may be enabled by adjusting theresistance of the variable resistance in the air circuit 4170 insynchrony with the breathing cycle.

7.6.2 Nasal Interface Examples

Various flow path strategies may be implemented to wash out exhaledcarbon dioxide given such different therapies and the differentconfigurations of the nasal interface when controlled in conjunctionwith any of the aforementioned pressure control regimes. These may beconsidered with reference to the flow arrows F of the figures. In theexample of FIG. 15A, either an inspiratory flow (i.e., cyclical supplyactivation) or a continuous flow may be supplied toward the patientnasal cavity via both of the nasal projections 16100 that may be inhaledby the patient during inspiration. The distal ends (DE) of the nasalprojections may be coupled with further supply conduits such as thatillustrated in FIG. 16. Expiratory gases may be exhausted from thepatient nasal cavities into the passage of the naris pillows and outthrough any one or more of the optional base vent 16220 and/or pillowvent(s) 18220. The control of a continuous exhaust flow via such ventsduring both inspiration and expiration can assist in ensuring washout ofexpiratory gases from the nasal cavities.

In the example of FIG. 15B, either an inspiratory flow (i.e., cyclicalsupply activation) or a continuous flow is supplied toward the patientnasal cavity via one of the nasal projections 16100 that may be inhaledby the patient during inspiration. In this example, although not shownin FIG. 15B, the distal end (DE) of the nasal projection on the left ofthe drawing may be coupled to a further supply conduit and a gas source.This flow supply nasal projection is shown on the left side of FIG. 15Bbut may alternatively be on the right. Expiratory gases may then beexhausted from the patient nasal cavities via the other nasal projection16100 (e.g., shown on the right of the figure). In this case, the distalend of one nasal projection may omit a further conduit and serve as apillow vent at the proximity of the naris pillow 16010. The control of acontinuous exhaust flow via such a vent during both inspiration andexpiration can assist in ensuring washout of expiratory gases from thenasal cavities.

In the example of FIGS. 17A and 17B, the presence of dual nasalprojections permits venting and supply via the nasal projections in eachnaris. Thus, either an inspiratory flow (i.e., cyclical supplyactivation) or a continuous flow is supplied toward the patient nasalcavity via one of the nasal projections 16100-2 of each naris pillowthat may be inhaled by the patient during inspiration. In this example,although not shown in FIG. 17B, the distal end DE of one nasalprojection of each naris pillow may be coupled to a further supplyconduit and a gas source. Expiratory gases may then be exhausted fromthe patient nasal cavities via the other nasal projection 16100-1 ofeach naris. In this case, the distal end of one nasal projection of eachnaris may omit a further conduit and serve as a pillow vent 18220 at theproximity of the naris pillow 16010. The control of a continuous exhaustflow via such vents during both inspiration and expiration can assist inimproving washout of expiratory gases (such as carbon dioxide) from thenasal cavities.

In some cases, the washout flow path may be implemented with a unitarynasal projection in each naris pillow. Such an example may be consideredin relation to FIG. 18. In this example, a gas supply nasal projectionis omitted. The unitary nasal projection 16100 in each naris pillow maythen serve as a nasal projection vent, such as by venting as a pillowvent. Thus, either an inspiratory flow (i.e., cyclical supplyactivation) or a continuous flow is supplied toward the patient nasalcavity via each naris pillow so that it may be inhaled by the patientduring inspiration. In this example, the distal end of the unitary nasalprojection 16100 may omit a further conduit and serve as a pillow vent18220 at the proximity of the naris pillow 16010. The control of acontinuous exhaust flow via such vents during both inspiration andexpiration can assist in ensuring washout of expiratory gases from thenasal cavities.

In some cases, the washout flow path may be implemented without nasalprojections. Such an example may be considered in relation to the nasalpillows of FIGS. 19A and 19B. In this example, each naris pillow mayhave a pillow vent for venting expiratory gases during expiration (SeeFIG. 19B). The pillow vent may be open during inspiration and expirationor only open during expiration. Either an inspiratory flow (i.e.,cyclical supply activation) or a continuous flow is supplied toward thepatient nasal cavity via each naris pillow 16010 so that it may beinhaled by the patient during inspiration (See FIG. 19A). The control ofa continuous exhaust flow via such vents during both inspiration andexpiration can assist in ensuring washout of expiratory gases from thenasal cavities. However, in the absence of the nasal projection there isa marginal increase in the deadspace.

In the example of FIGS. 20A and 20B, vents at the neck or base of eachnaris pillow may be activated by an optional vent valve 21410. Thesenaris pillows may optionally include any of the nasal projectionspreviously described. In this version, the vent valve may be activatedby rising pressure associated with the patient's expiratory cycle so asto permit cyclical venting at the patient's naris pillow. Thus, asillustrated in FIG. 20A, during expiration, expiratory gases open thevent valve to expel expiratory air to atmosphere. At this time, the flowpath from the air circuit 4170 to the naris pillow may be blocked. Asillustrated in FIG. 20B, during inspiration, supply gas from the flowgenerator or CT device may close the vent valve. At this time, the flowpath from the air circuit 4170 to the naris pillow may be open.

In another example of FIGS. 20C and 20D, such valves 21410 may beconfigured so that only some of the pillow vents 18220 are closed at anyone time. In this arrangement, the valves 21410 may be configured sothat one pillow vent is opened, while the other is closed. Referring nowto FIG. 20C, the pillow vent to the left of the figure is open, whilethe pillow vent to the right is closed, and thus expiratory flow fromthe patient exits through the open pillow vent. During inhalation, asshown in FIG. 20D, the flow generator or CT device delivers a flow ofsupply gas, which is delivered to the patient while the pillow vent tothe left remains open, thereby continuously washing out gases which hasthe effect of reducing dead space. An alternative arrangement is shownin FIGS. 20E and 20F, wherein the pillow vent to the left is closed andthe pillow vent to the right is open. In one form, the valves 21410 maybe arranged so that they are switchable from a first arrangement, forexample shown in FIGS. 20C and 20D to a second arrangement for exampleshown in FIGS. 20E and 20F. For example, in the case of anelectromagnetic operation of the valves, they may be set to the desiredoperation by a controller. For example, they may be alternated on apredetermined or pre-set time cycle. Optionally, the valves may bemanually operated and may be manually switched at a desired time.

One advantage of switching from the first to the second arrangement andthus alternating between the left and right nasal passages as describedabove may be that it may improve the patient's comfort level. Forinstance, the patient using the patient interface as shown in FIGS.20C-20D may experience discomfort from drying out of the patient's right(left on the figure) nasal passage, which may be alleviated by changingthe configuration of the patient interface to that shown in FIGS.20E-20F.

Optionally, such a valve may be extended into a nasal projection (e.g.shown in FIG. 21) such that the nasal projection may serve as bothsupply and exhaust conduit. In such a case, the nasal projection mayinclude a valve membrane 22500 that divides the conduit. The valvemembrane 22550 may be flexible and extend along the nasal projection16100 from or near the proximal end toward a vent portion 22510 of thenasal projection. The vent portion may be proximate to or serve as apillow vent 18220. The valve membrane 22550 of the nasal projection maybe responsive to inspiratory and expiratory flow such that it may move(See Arrow M of FIG. 22) dynamically across the channel of the nasalprojection as illustrated in FIGS. 22, 23A and 23B. The valve membranemay then dynamically reconfigure the nasal projection as an inspiratoryconduit and expiratory conduit on either side of the membrane. Forexample, as shown in FIG. 23A, responsive to patient expiration,movement of the valve membrane 22550 across the proximal end of thenasal projection enlarges an expiratory channel portion ECP of theprojection that leads to the vent portion 22510. This movement therebyreduces an inspiratory channel portion ICP of the nasal projection thatleads to a supply gas source or flow generator. Similarly, as shown inFIG. 23B, responsive to patient inspiration, return movement of thevalve membrane 22550 across the proximal end of the nasal projectionreduces an expiratory channel portion ECP of the projection that leadsto the vent portion 22510. This movement thereby expands an inspiratorychannel portion ICP of the nasal projection that leads to a supply gassource or flow generator.

Nasal interfaces such as the nasal mask 3000 or the pillows interface16002 have an advantage over oro-nasal interfaces in that they moreeasily permit the patient to speak and eat while receiving combinationtherapy. In addition, when the patient opens his or her mouthincidentally, for example during sleep, the open mouth acts as anaperture through which leak may occur. Whether mouth opening isincidental or purposeful to speak or eat, it would be helpful for thecontrol of combination therapy to detect such an occurrence. Mouth leakmay be continuous or “valve-like”, occurring intermittently when mouthpressure rises during exhalation. Both kinds of mouth leak may bedetected by estimating and analysing the respiratory flow rate Qr, forexample using the methods described in PCT Patent Publication no. WO2012/012835, the entire contents of which are herein incorporated bycross-reference. If a continuous mouth leak is detected by thecontroller, the target interface pressure Pm may be reduced by thecontroller, e.g. to zero, for the duration of the mouth opening, toreduce what is often the unpleasant sensation of air rushing out themouth and to enable the patient to eat or speak more comfortably.However, the controller may optionally continue to control delivery ofthe deadspace therapy throughout any of the detected mouth leak events.

In a further implementation, an intentional flow of air out the mouthmay be enabled and controlled by a specially designed oral appliance tobe worn by the patient during therapy, e.g. during sleep. Such a mouthflow may act as an alternative or supplementary path to ambient for theflushing flow entering the nasal cavity. The effect of the oralappliance may be modelled in the electrical circuit model 2700 of FIG.27 by a further resistive element between the nose and ambient, i.e. inparallel with the airway path on the far right of the model 2700. Thepresence of this element, and the mouth flow rate Qmouth through it,effectively adds Qmouth to the ceiling Q2(max) on the flushing flow rateQ2 for any given interface pressure Pm.

7.6.3 Oro-Nasal Interface Examples

In another form, an oro-nasal (full-face) mask may comprise one moreflow directors configured to deliver a flow of gas towards the nares ofthe user. The flow directors may be connected to, and receive the flowof gas from a supplemental gas source such as an oxygen source or a flowgenerator suitable for HFT. For example, the patient interface maycomprise one or more secondary ports 19100 as shown in FIG. 24connectable to the supplemental gas source such as via a supply conduit.

One example of the flow directors may be one or more tubes 19200 coupledto one or more secondary ports 19100 and located outside of a naris of apatient to direct the flow of gas as shown in FIG. 25A. The one or moretubes 19200 may be a separable component which can be engaged with theframe of the patient interface (e.g. mask) as shown in FIG. 25A, wherethe tubes 19200 are engaged within the plenum chamber 3200. In someforms, the one or more tubes 19200 may be integrally formed with anotherportion of the patient interface such as the plenum chamber 3200. Theone or more tubes 19200 may be movably configured relative to the restof the patient interface, such as pivotably coupled to the mask as shownin FIG. 25A, to be able to adjust the direction of the flow of gas.

A flow director may further comprise a locating feature to allow theflow director to remain in place once it has been adjusted, for exampleby frictional engagement with the plenum chamber 3200. Although thearrangement shown in FIG. 25A shows two such tubes that are fluidlyconnected to each other, as well as to the secondary ports 19100, itwill be understood that any number of ports and tubes may be used, aswell as any combination of connections therebetween, analogously withthe above descriptions of nasal projections. In another example, eachtube 19200 may be independently connected to the plenum chamber 3200using hollow spherical joints (not shown) which allow a flow of gastherethrough, while also allowing movements of the tube relative to therest of the patient interface. Such a connection may thereby allow aflow of gas to travel between a secondary port 19100 and the tube 19200.

In some cases, a flow director may be in a form of a flow directingsurface 19300 coupled to a secondary port 19100. For instance, each flowdirecting surface shown in FIG. 25B may comprise a curved surface shapedto direct the flow of gas from the supplemental gas source using theCoanda effect, whereby the flow “attaches” or conforms to the curvedsurface and follows its profile. In some forms, the flow directingsurface 19300 may be movably configured, for example by being rotatablycoupled to the plenum chamber 3200.

According to another aspect, a flow director or a nasal projection maycomprise a flow element, such as a honeycomb grid (not shown), to reduceturbulence of the flow, whereby the flow director produces a morelaminar flow than otherwise. Such an arrangement may be particularlyadvantageous when used in conjunction with a flow director, as a laminarflow may be more focussed in comparison to a turbulent flow as it exitsout of an orifice. Accordingly, use of a flow element may assist indelivering a greater proportion of the flow of gas to the naris of thepatient, whereas without a flow element, more of the flow of gas may belost to the interior of the mask and possibly washed out through a vent.

7.6.4 Example Flow/Pressure Control Methodology

FIG. 29 shows a flow diagram 2900 in accordance with an aspect of thedisclosed systems and methods. Each block of flow diagram 2900 may beperformed by one or more controllers of a single device, such as CTdevice 4000, or by controllers of multiple devices. Various blocks maybe performed simultaneously or in a different order than shown. Inaddition, operations or blocks may be added or removed from the flowdiagram and still be in accordance with aspects of the disclosedtechnology.

In block 2902, a controller may identify a predetermined pressure and apredetermined flow rate of the air to be provided to a patientinterface. As described above, the predetermined pressure and/or thepredetermined flow rate may be constant or variable for a given periodof time, and may be selected based on a desired therapy or combinationof therapies to be provided to the patient. For example, a bi-levelpressure therapy may be selected for which the predetermined pressure ofthe air is to be adjusted based on the patient's inspiration andexpiration, while the predetermined flow rate may be maintained at aconstant level in accordance with a selected form of HFT. In block 2904,a controller may receive a measurement of the current pressure and thecurrent flow rate, as measured by a pressure sensor and a flow ratesensor, respectively. A controller may compare the measured pressure andflow rate with the predetermined pressure and the predetermined flowrate, respectively (block 2906). The comparison may include determiningwhether the measured pressure and flow rate are at or within anacceptable range with respect to the predetermined pressure and thepredetermined flow rate. If the measured pressure and flow ratecorrespond to the predetermined pressure and flow rate, the controllermay return to block 2904.

If the measured pressure or flow rate does not correspond to thepredetermined pressure or flow rate, the controller may adjust theoutput of one or more flow generators and/or may adjust one or moreparameters of an adjustable vent in a manner described above (block2908). For example, the system may include two flow generators, such aspressure device 4140 and a flow device 4141 described above. If themeasured pressure does not correspond to the predetermined pressure, thecontroller may adjust the output of either one or both of the flowgenerators, so as to bring the measured pressure into correspondencewith the predetermined pressure. The adjustment to the output of one orboth of the flow generators may be performed so that the measured flowrate continues to correspond with the predetermined flow rate. In thisway, the pressure and flow rate are simultaneously controlled. Thecontroller may return to block 2904 until the selected therapy sessionis terminated or the device is no longer in use (block 2910).

7.6.5 Titration of Combination Therapy

The optimal parameters (e.g., pressure and flow rate) of combinationtherapy, in particular the balance between the two therapies, i.e. theposition on the curve 32030, in combination therapy will vary frompatient to patient. The process of choosing the therapy parameters for apatient is known as titration. In general the parameters may be chosenor varied based on the patient's condition as well as respiratoryparameters such as minute ventilation, respiratory rate, expiratory flowshape, lung mechanics, deadspace, and expired CO₂. For example, patientswith severe NMD need a predominance of pressure support to assist in thework of breathing, whereas emphysemic patients may benefitproportionally more from deadspace therapy. Patients with large lungvolume with low pressure support may indicate high deadspace andtherefore proportionally more benefit from deadspace therapy.Conversely, high respiratory rate indicating significant respiratoryeffort may benefit more from pressure support.

One form of pressure support therapy known as iVAPS is based onservo-control of alveolar ventilation by varying pressure support. IniVAPs, the target level of ventilation is an alveolar ventilationcomputed by subtracting anatomical deadspace ventilation from minuteventilation. The amount of anatomical deadspace for a given patient is asetting that may be provided to the servo-controller or estimated fromthe patient's height. In combination with deadspace therapy, acontroller controlling this form of pressure support therapy may apply alower value of anatomical deadspace than would be expected for thepatient without the deadspace therapy such as by implementing areduction value applied to the entered or computed anatomical deadspaceinformation so that the controller can compute a target ventilationsetting for alveolar ventilation that accounts for the DST. A lowervalue of deadspace ventilation will result in an alveolar ventilationthat is closer to the minute ventilation. Hence the controller with sucha calculated ventilation target will control generally lower levels ofpressure support.

7.6.6 Cardiac Output Estimation

The Fick technique estimates cardiac output by estimating the responsein expired CO₂ to a deadspace manoeuvre (typically a step change indeadspace). The flushing flow rate in deadspace therapy can be used toeffectively manipulate deadspace, and a measure of ventilation (e.g.,minute ventilation or tidal volume) can be used as a proxy for CO₂response, particularly during sleep. Therefore, the Fick technique canbe performed in combination therapy by measuring the change inventilation (e.g., minute ventilation or tidal volume) resulting from astep change in flushing flow rate. For example, a controller may beimplemented to calculate or generate a cardiac output estimate bycontrolling a step change in the flushing flow rate and determiningchange in a measure of ventilation (e.g., minute ventilation or tidalvolume) in relation to the step change in accordance with the Ficktechnique. Such a process may be automatically initiated (orperiodically) by the controller such as during a sleep session, such aswhen sleep has been detected by the controller. The controller maydetect sleep by any known method, such as by any of the automatedmethods described in International Patent Application no.PCT/AU2010/000894 (WO/2011/006199) entitled “Detection of SleepCondition”, the entire disclosure of which is incorporated herein byreference.

7.7 Additional Patient Interfaces for Optional Therapies

Some patients have a need for multiple therapies. For example, somepatients may require supplemental gas therapy. For example, supplementaloxygen therapy may be delivered to the patient by use of a nasal cannulawhere prongs of the cannula supply the oxygen at the patient's nares.Unlike nasal CPAP, such a therapy does not typically supply the air attherapeutic pressure(s) so as to treat events of sleep disorderedbreathing such as obstructive apnea or obstructive hypopneas.Supplemental oxygen therapy may be considered with reference to theillustration of FIG. 6. The traditional nasal cannula 7002 includesnasal prongs 7004A, 7004B which can supply oxygen at the nares of thepatient. Such nasal prongs do not generally form a seal with the inneror outer skin surface of the nares. The gas to the nasal prongs maytypically be supplied by one or more gas supply lumens 7006 a, 7006 bthat are coupled with the nasal cannula 7002. Such tubes may lead to anoxygen source. Alternatively, in some cases, such a nasal cannula 7002may provide a high flow therapy to the nares. Such a high flow therapy(HFT) may be that described in U.S. Patent Application Publication No.2011-0253136 filed as International Application PCT/AU09/00671 on May28, 2009, the entire disclosure of which is incorporated herein by crossreference. In such a case, the lumen from the nasal cannula leads to aflow generator that generates the air flow for high flow therapy.

During delivery of such supplemental gas therapies with a traditionalnasal cannula, it may be desirable to periodically provide a furthertherapy, such as a pressurized gas therapy or positive airway pressure(PAP) therapy that requires a patient interface to form a pressure sealwith the patient's respiratory system. For example, during oxygentherapy with a traditional nasal cannula, it may be desirable to providea patient with a traditional CPAP therapy when a patient goes to sleep,or traditional pressure support therapy. These additional therapies mayrequire a mask such as a nasal mask or oro-nasal (mouth and nose) maskthat may optionally include an adjustable vent. Such an example may beconsidered with reference to FIG. 7. When the mask 8008 is applied tothe patient over the traditional nasal cannula, one or more of thecomponents of the nasal cannula may interfere with the mask's sealforming structure (e.g., cushion 8010) so as to prevent a good seal withthe patient. For example, as shown in FIG. 7, the lumens 7006 a, 7006 bmay interfere with a cushion 8010 of the mask. This may result in asubstantial cannula induced leak (CIL) at or near the lumen which mayprevent the desired therapy pressure levels from being achieved in themask. Apparatus and therapies described herein may be implemented toaddress such issues so as to permit simultaneous pressure and flowcontrol.

7.7.1 Modified Nasal Cannula Embodiments

In some implementations of the present technologies, a modified nasalcannula may be implemented to permit its use with changing therapyneeds. For example, as illustrated in FIG. 8, the nasal cannula 9002includes a set of projections (e.g., one or more prongs 9004 a, 9004 b).Each projection or prong may extend into a naris of a user. Theprojection serves as a conduit to deliver a flow of gas into the narisof the user. The nasal cannula 9002 will also typically include one ormore coupler extensions 9020 a, 9020 b. The coupler extension may serveas a conduit to conduct a flow of gas from a gas supply line, such aslumen 9012 a, 9012 b. The coupler extension may be removably coupleablewith a base portion 9022 of the nasal cannula 9002 and/or the supplyline(s) of the cannula. Alternatively, the coupler extension may beintegrated with either or both.

Typically, each coupler extension(s) may be configured with a seatportion 9024 a, 9024 b. The seat portion may include a contact surfacefor another patient interface. For example, the seat portion can serveas a contact surface for a typical seal forming structure (e.g., atypical face contact cushion) of a mask so as to permit a seal therebetween. Thus, the contact surface of the seat portion may form a sealwith a cushion of a mask. The coupler extension will also typicallyinclude a contact surface for skin/facial contact with a patient to forma seal there between. The seat portion can include a surface adapted tominimize or eliminate a cannula induced leak CIL. In some such cases, itmay include a surface with a sealing bevel 9090. The sealing bevel 9090may promote sealing between the cushion of the mask and a facial contactsurface. In this way, it may fill a gap that would otherwise be inducedby a traditional nasal cannula structure.

The sealing bevel of the seat portion may be formed with various crosssectional profiles to promote sealing. For example, as illustrated inFIG. 9A, the seat portion 9024 of the coupler extension may have agenerally triangular cross sectional profile. It may be a triangle, forexample an isosceles triangle, with the mask sealing surface on thesides opposite the base. Thus, the sides opposite the base may be equalor of different lengths. The base 9026 may typically be configured asthe patient sealing surface. Other cross sectional profiles may also beimplemented. For example, FIGS. 9B, 9C and 9D show a lentil crosssectional profile. Thus, as illustrated, the profile may be largercentrally and the top and bottom surfaces may gradually converge bysimilar slopes toward the opposing ends of the profile.

In some cases, the coupler extension(s) may serve as a conduit forconducting air between the prongs of the nasal cannula and lumen. Forexample, as illustrated in FIGS. 9A, 9B, 9C and 9D, the seat portion mayinclude one or more channel conduits 10030. The channel conduits may beemployed for directing gas in different gas flow directions with respectto the nasal cannula, to provide gas to different prongs and/or toprovide different gases etc. For example, one channel conduit may leadto one prong of the nasal cannula and another channel conduit, ifincluded, may lead to the other prong of the nasal cannula. As shown inFIG. 9A and 9C, a single channel conduit is provided. The single channelconduit is round and may couple with a tube shaped lumen. However, itmay be other shapes, e.g., rectangular. This channel conduit may lead toboth prongs or one prong when coupled with the nasal cannula. As shownin FIG. 9B and 9D, a double channel conduit is provided. Each channel ofthe double channel conduit may have a round, oval or other similarprofile and may couple with a tube shaped lumen. Each channel doubleconduit shown in FIG. 9b is rectangular and may be divided by a ribdivider structure 10032 centrally located within the coupler extension.Each channel may lead to both prongs or each channel may lead to adifferent prong when coupled with the nasal cannula. Additional channelconduits may also be provided for example, by providing additional ribdividers.

As shown in FIG. 10A and 10B, when a mask is placed over the nasalcannula, such that the nasal cannula will be contained within the plenumchamber, the mask rests not only on the patient's facial contact areasbut also on the seat portion of the nasal cannula. As furtherillustrated in FIG. 10B, the profile of the seat portion permits a sealbetween the seal forming structure of the mask so as to reduce gaps.Thus, the seat portion will typically have a length L and width W (see,e.g., FIG. 8 or FIG. 14A) adapted to receive typical mask cushions. Thelength may be longer than a typical cushion width. The length may bechosen to ensure seal during lateral displacement of the mask. Ameasurement from 0.5 to 3.0 inches may be a suitable length range. Forexample, an approximately two inch length may be suitable. The width mayvary depending on the height of the channel conduits and typicalflexibility characteristics of mask cushion materials so as to ensure agradual sealing bevel that will avoid gaps.

The coupler extension may be formed by moulding, such as with a flexiblematerial. For example, it may be formed of silicone. Optionally, theouter or end portions may be more rigid than the central section such asby having a solid cross section. The greater rigidity at the ends of thecross section may help with limiting their deformation so as to maintaintheir shape and avoid creation of gaps between the mask cushion andfacial contact areas during use. In some versions of the couplerextension additional materials may be applied such as for improvingcompliance. For example, a skin contact surface may include a foam layeror soft material for improved comfort.

Although the version of the modified nasal cannula of FIG. 10A includesa single supply line on each side of the cannula (e.g., left side andright side supply lines), additional supply lines may be implemented.For example, as illustrated in FIGS. 11 and 12, two lumens are appliedor protrude from each coupler extension. In some such cases, each lumenmay be coupled with a different channel conduit of the couplerextension. In such arrangements, the lumens may be split above and/orbelow an ear to provide a more secure fitment for the patient.

Optionally, the seat portion of any of the cannula described herein mayinclude a mask fitment structure, such as a seat ridge. The ridge canserve as a locating feature to indicate, or control, a relative positionof the mask with respect to the seat portion. Such a seat ridge 12040feature is illustrated in FIGS. 11 and 12. The seat ridge may rise fromthe surface of the seat portion such as on an outer area or edge of theseat portion (in a direction normal to the sagital plane).

FIG. 13 illustrates another version of the coupler extension of thepresent technology. In this version, the width of the seat portionincludes an expansion area EA that expands the seat portion centrallyalong its length. Such a variation in the contact surface of the seatportion may assist in improving the seal between the seat portion and amask cushion and/or the comfort of the seal between the couplerextension and the patient's facial contact area.

In some versions of the present technology a coupler extension 15020 maybe formed as an add-on component for a traditional nasal cannula. Suchan add-on coupler extension may be considered with reference to FIGS.14A-14C. The add-on coupler extension 15020 may include one or moregroove(s) 15052 for insertion of a supply line such as a lumen of acannula. Thus, the coupler extension with its seat portion and sealingbevel may be easily applied to or under a lumen of a nasal cannula toreduce gaps when a mask is applied over the lumen of the traditionalcannula. The coupler extension 15020 may also include any of thefeatures of the coupler extensions previously described. For example, asshown in FIGS. 14A, 14B, and 14C it may have various cross sectionalprofiles such as triangular profile and lentil profiles. In the versionof FIG. 14C, two grooves 15052 are provided for insertion of two lumens,such as in the case that the traditional cannula includes two lumensextending out from one or both sides of the cannula. Although thefigures have illustrated nasal cannula with two prongs, it will beunderstood that a nasal cannula of the present technology may beimplemented with one or more nasal prongs (e.g., two).

7.7.2 Modified Nasal Pillow Embodiments

In some versions of the present technology, a common patient interfacemay provide a unitary structure for permitting application of varioustherapies. Thus, unlike the prior embodiments, the use and periodicapplication of an additional patient interface for varying therapy maynot be necessary. Moreover, features of such a patient interface may bedesigned to minimize dead space.

One such patient interface example that can be implemented for periodicapplication of various therapies, for example an oxygen therapy and aPAP therapy, may be considered with reference to FIGS. 15A and 15B. Thepatient interface 16002 may serve as a nasal interface. Thus, it mayinclude a set of naris pillows (e.g., one or more naris pillow(s)16010). Each naris pillow may be flexible and may be configured to forma seal with the naris of a patient when worn. The naris pillow may havean outer conical surface 16012 that may engage at a skin periphery of apatient's naris either internal and/or externally of the nostril.Optionally, the naris pillow may also have an inner conical portion16014 in a nested relationship with the outer conical portion (best seenin FIG. 17B). A gap may exist between the inner conical portion 16014and the outer conical surface 16012. Each naris pillow may couple by aneck 16015 portion to a common base portion 16016. A passage through thecentral area of the outer conical portion (and/or inner conicalportion), neck and base portion may serve as a flow path to and/or froma flow generator of CT device 4000 via an air circuit 4170. The aircircuit 4170 may be coupled to the base portion 16016 of the patientinterface at a flange 16018 (best seen in FIG. 17B). Optional baseextensions 16020-1, 16020-2 may include connectors 16022-1, 16022-2 forconnection of the patient interface with a stabilizing and positioningstructure (e.g., straps or other headgear.)

One or both of the naris pillows may also include one or more nasalprojections. Each nasal projection 16100 may be a conduit to conduct aflow of gas through the nasal projection. The nasal projection willtypically project from the nasal pillow. As illustrated in FIG. 15A and15B, the nasal projection may be configured to extend beyond the seal ofthe naris pillow (e.g., beyond the edge of the outer conical portion) sothat it may project into or extend into the nasal cavity of a patientwhen used further than the naris pillow at a proximal end PE. The nasalprojection 16100 may emanate from within the flow passage of the narispillow (e.g., extend out of a conical portion). The nasal projection mayoptionally adhere to an inside wall of the naris pillow or otherinternal passage of the patient interface. In some cases, the nasalprojection may be integrated with or formed with an inside wall of thenaris pillow or other internal passage of the patient interface.Nevertheless, flow passage of the nasal projection will be discrete fromthe flow passage of the naris pillow. Typically, the length of theextension into a nasal cavity by the nasal projection may be in a rangeof about 5 mm to 15 mm.

Optionally, as shown in the version of FIGS. 15A and 15B, each nasalprojection may extend through a passage of the naris pillow and apassage of the base portion. At a distal end DE of the nasal projection,the nasal projection may be removeably coupled to (or integrated with) afurther conduit to a gas supply, such as a flow generator orsupplemental gas source (e.g., an oxygen source). Alternatively, at adistal end DE of the nasal projection, the nasal projection may be opento atmosphere, such as to serve as a vent. In some cases, the distal endDE of the nasal projection may have a removable cap so as to close thedistal end and thereby prevent flow through the nasal projection. Forexample, as illustrated in FIG. 16, a projection conduit 17170-1,17170-2 may optionally be coupled to each of the nasal projections.Optionally, the projection conduits 17170 extend along and are externalof the air circuit 4170. However, these projection conduits may extendalong and are internal of the air circuit 4170 such as when they extendfrom the base portion 16016 and through the flange 16018 as illustratedin FIG. 17B.

In some versions of the patient interface 16002, one or more vents maybe formed at or from a surface of the patient interface. In otherversions, another component (e.g. an adapter or an air circuit 4170)including one or more vents may be fluidly coupled to the patientinterface. The vent may serve as a flow passage to vent expired air fromthe apparatus. Optionally, such a base vent 16220 may be formed on thebase portion 16016 as illustrated in FIG. 15A so as to vent from thechamber inside the base portion. In some cases, one or more vents may beformed on the naris pillow, such as on the neck 16015. In some cases,one or more vents may be formed on a part of the outer conical surface16012 such as to vent from the chamber within the naris pillow portionof the patient interface. In some cases, such a vent may be a fixedopening with a known impedance. In some such cases, the vent may providea known leak. Optionally, such a vent may be adjustable, such as by amanual manipulation, so as to increase or decrease an opening size ofthe vent. For example, the vent may be adjusted from fully open,partially open and closed positions, etc. In some cases, the vent may bean electro-mechanical vent that may be controlled by the flow generatorso as increase or decrease the size of the vent between various openingand closed positions. Example vents and control thereof may beconsidered in reference to International Patent Application No.PCT/US2012/055148 filed on Sep. 13, 2012 and PCT Patent Application No.PCT/AU2014/000263 filed on Mar. 14, 2014, the entire disclosures ofwhich are incorporated herein by reference.

By way of example, in the patient interface 16002 of FIGS. 17A and 17B,the nasal interface includes multiple nasal projections 16100 extendingfrom each naris pillow. At least one such nasal projection may serve asa pillow vent 18220 for example, at a bottom portion of the outerconical surface of the naris pillow. In the example, the nasalprojections 16100-1 each form a conduit that lead to atmosphere throughthe naris pillow from the nasal cavity of a patient. With such a nasalprojection extending into the nasal cavity, a patient's deadspace can bereduced through a shortened pathway for expired air (carbon dioxide) tobe removed from the patient's airways. In some such examples, theadditional nasal projections 16100-2 may be coupled with a supplementalgas source such as an oxygen source or a controlled flow of air asdiscussed in more detail herein. Optionally, such nasal projections ofeach naris pillow may be formed with a deviating projection (shown inFIG. 17A at arrows DB). Such a deviation such that they are furtherapart at the proximal end when compared to lower portions can assistwith holding the extensions within the nasal cavity during use. Thus,they may gently ply within a nasal cavity on opposing sides of the nasalcavity.

7.8 Glossary

For the purposes of the present technology disclosure, in certain formsof the present technology, one or more of the following definitions mayapply. In other forms of the present technology, alternative definitionsmay apply.

7.8.1 General

Air: In certain forms of the present technology, air may refer toatmospheric air as well as other breathable gases. For instance, airsupplied to a patient may be atmospheric air or oxygen, and in otherforms of the present technology, air may comprise atmospheric airsupplemented with oxygen.

Ambient: In certain forms of the present technology, the term ambientwill be taken to mean (i) external of the treatment system or patient,and (ii) immediately surrounding the treatment system or patient.

7.8.2 Anatomy of the Respiratory System

Diaphragm: A sheet of muscle that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, containing the heart,lungs and ribs, from the abdominal cavity. As the diaphragm contractsthe volume of the thoracic cavity increases and air is drawn into thelungs.

Larynx: The larynx, or voice box houses the vocal folds and connects theinferior part of the pharynx (hypopharynx) with the trachea.

Lungs: The organs of respiration in humans. The conducting zone of thelungs contains the trachea, the bronchi, the bronchioles, and theterminal bronchioles. The respiratory zone contains the respiratorybronchioles, the alveolar ducts, and the alveoli.

Nasal cavity: The nasal cavity (or nasal fossa) is a large air filledspace above and behind the nose in the middle of the face. The nasalcavity is divided in two by a vertical fin called the nasal septum. Onthe sides of the nasal cavity are three horizontal outgrowths callednasal conchae (singular “concha”) or turbinates. To the front of thenasal cavity is the nose, while the back blends, via the choanae, intothe nasopharynx.

Pharynx: The part of the throat situated immediately inferior to (below)the nasal cavity, and superior to the oesophagus and larynx. The pharynxis conventionally divided into three sections: the nasopharynx(epipharynx) (the nasal part of the pharynx), the oropharynx(mesopharynx) (the oral part of the pharynx), and the laryngopharynx(hypopharynx).

7.8.3 Aspects of PAP Devices

APAP: Automatic Positive Airway Pressure. Positive airway pressure thatis continually adjustable between minimum and maximum limits, dependingon the presence or absence of indications of SDB events.

Controller: A device, or portion of a device that adjusts an outputbased on an input. For example one form of controller has a variablethat is under control—the control variable—that constitutes the input tothe device. The output of the device is a function of the current valueof the control variable, and a set point for the variable. Aservo-ventilator may include a controller to provide a ventilationtherapy. Such a ventilation therapy has ventilation as an input, atarget ventilation as the set point, and level of pressure support as anoutput. Other forms of input may be one or more of oxygen saturation(SaO₂), partial pressure of carbon dioxide (PCO₂), movement, a signalfrom a photoplethysmogram, and peak flow. The set point of thecontroller may be one or more of fixed, variable or learned. Forexample, the set point in a ventilator may be a long term average of themeasured ventilation of a patient. Another ventilator may have aventilation set point that changes with time. A pressure controller maybe configured to control a blower or pump to deliver air at a particularpressure. A flow controller may be configured to control a blower orother gas source to deliver air at a particular flow rate.

Therapy: Therapy in the present context may be one or more of positivepressure therapy, oxygen therapy, carbon dioxide therapy, deadspacetherapy, and the administration of a drug.

7.8.4 Terms for Ventilators

Adaptive Servo-Ventilator: A ventilator that has a changeable, ratherthan fixed target ventilation. The changeable target ventilation may belearned from some characteristic of the patient, for example, arespiratory characteristic of the patient.

Backup rate: A parameter of a ventilator that establishes the minimumrespiration rate (typically in number of breaths per minute) that theventilator will deliver to the patient, if not otherwise triggered.

Cycled: The termination of a ventilator's inspiratory phase. When aventilator delivers a breath to a spontaneously breathing patient, atthe end of the inspiratory portion of the breathing cycle, theventilator is said to be cycled to stop delivering the breath.

Pressure support: A number for a ventilation therapy that is indicativeof the increase in pressure during ventilator inspiration over thatduring ventilator expiration, and generally means the difference inpressure between the maximum value during inspiration and the minimumvalue during expiration (e.g., PS=IPAP−EPAP). In some contexts pressuresupport means the difference which the ventilator aims to achieve,rather than what it actually achieves.

Servo-ventilator: A ventilator that provides a ventilation therapy forwhich the device measures patient ventilation, has a target ventilation,and which adjusts the level of pressure support to bring the patientventilation towards the target ventilation.

Spontaneous/Timed (S/T)—A mode of a ventilator or other device thatattempts to detect the initiation of a breath of a spontaneouslybreathing patient. If however, the device is unable to detect a breathwithin a predetermined period of time, the device will automaticallyinitiate delivery of the breath.

Triggered: When a ventilator delivers a breath of air to a spontaneouslybreathing patient, it is said to be triggered to do so at the initiationof the respiratory portion of the breathing cycle by the patient'sefforts.

Ventilation: A volumetric measure of gas being exchanged by thepatient's respiratory system, such as a tidal volume. Measures ofventilation may include one or both of inspiratory and expiratory flow,per unit time. When expressed as a volume per minute, this quantity isoften referred to as “minute ventilation”. Minute ventilation issometimes given simply as a volume, understood to be the volume perminute. A ventilation therapy can provide a volume of gas for patientrespiration so as to perform some of the work of breathing.

Ventilator: A mechanical device that provides pressure support to apatient to perform some or all of the work of breathing.

7.9 Other Remarks

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightrights whatsoever.

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being preferably used toconstruct a component, obvious alternative materials with similarproperties may be used as a substitute. Furthermore, unless specified tothe contrary, any and all components herein described are understood tobe capable of being manufactured and, as such, may be manufacturedtogether or separately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated by reference todisclose and describe the methods and/or materials which are the subjectof those publications. The publications discussed herein are providedsolely for their disclosure prior to the filing date of the presentapplication. Nothing herein is to be construed as an admission that thepresent technology is not entitled to antedate such publication byvirtue of prior invention. Further, the dates of publication providedmay be different from the actual publication dates, which may need to beindependently confirmed.

Moreover, in interpreting the disclosure, all terms should beinterpreted in the broadest reasonable manner consistent with thecontext. In particular, the terms “comprises” and “comprising” should beinterpreted as referring to elements, components, or steps in anon-exclusive manner, indicating that the referenced elements,components, or steps may be present, or utilized, or combined with otherelements, components, or steps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein may have been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative embodiments and that other arrangements may bedevised without departing from the spirit and scope of the technology.

1. A system for delivery of a flow of air to a patient's airwayscomprising: a flow generator configured to provide air to a patient viaan air circuit and a patient interface; an adjustable vent; and one ormore controllers configured to: determine a pressure and a flow rate ofthe air being provided to the patient via the patient interface with aplurality of sensors; and control the flow generator and the adjustablevent so as to simultaneously control the pressure and the flow rate ofthe air at the patient interface to correspond with a predeterminedpressure and a predetermined flow rate, respectively.
 2. The system ofclaim 1 further comprising the patient interface, wherein the patientinterface comprises a projection portion configured to conduct a flow ofthe air into a naris of a patient and a mask portion configured to applypressure of the air to the patient.
 3. The system of claim 2, whereinthe adjustable vent is part of the mask portion of the patientinterface.
 4. The system of claim 2, wherein the plurality of sensorscomprise: a pressure sensor for determining a measured pressure of theair; and a flow rate sensor for determining a measured flow rate of theair through the projection portion of the patient interface.
 5. Thesystem of claim 4, wherein at least one of the pressure sensor and theflow rate sensor is located at an output of the flow generator.
 6. Thesystem of claim 4, wherein at least one of the pressure sensor and theflow rate sensor is located at the patient interface.
 7. The system ofclaim 1, wherein the one or more controllers are further configured tomaintain at least one of the predetermined pressure and thepredetermined flow rate at a constant value for a period of time.
 8. Thesystem of claim 1, wherein the one or more controllers are furtherconfigured to vary the predetermined pressure in accordance with abreathing cycle of the patient.
 9. The system of claim 1, wherein thesimultaneous control of the pressure and the flow rate of the airprovides the patient with a positive airway pressure therapy and adeadspace therapy.
 10. The system of claim 9, wherein the positiveairway pressure therapy is a ventilation therapy.
 11. The system ofclaim 1, wherein the one or more controllers are configured to determinethe predetermined pressure and the predetermined flow rate to restrictthe predetermined pressure and the predetermined flow rate to a curve ofequal efficacy.
 12. The system of claim 1 further comprising a variableresistance in the air circuit, wherein the one or more controllers areconfigured to control one or more of the pressure and the flow rate ofthe air by adjusting the resistance of the variable resistance.
 13. Thesystem of claim 1, wherein a controller of the one or more controllersis configured to compute a target ventilation based on anatomicaldeadspace information and a deadspace therapy reduction value.
 14. Thesystem of claim 1, wherein a controller of the one or more controllersis configured to generate a cardiac output estimate by controlling astep change in the predetermined flow rate of the air and determining achange in a measure of ventilation in relation to the step change. 15.The system of claim 14, wherein the controller of the one or morecontrollers is configured to initiate control of the step change in thepredetermined flow rate of the air in response to a detection of sleep.16. A method for controlling a supply of air to a patient's airways fora respiratory therapy, the method comprising: identifying, by one ormore controllers, a predetermined pressure and a predetermined flow rateof the air to be provided to a patient via an air circuit and a patientinterface; determining, with a plurality of sensors, a pressure and aflow rate of the air being provided to the patient via the patientinterface; and controlling, by the one or more controllers, a flowgenerator configured to provide the air to the patient interface, and anadjustable vent so as to simultaneously control the pressure and theflow rate of the air at the patient interface to correspond with thepredetermined pressure and the predetermined flow rate, respectively.17. The method of claim 16, wherein the patient interface comprises aprojection portion configured to conduct a flow of the air into a narisof the patient and a mask portion configured to apply pressure of theair to the patient.
 18. The method of claim 17, wherein the flowgenerator provides the flow of the air through the projection portion ofthe patient interface thereby applying pressure of the air to the maskportion of the patient interface.
 19. The method of claim 16 furthercomprising maintaining, by the one or more controllers, at least one ofthe predetermined pressure and the predetermined flow rate at a constantvalue for a period of time.
 20. The method of claim 16 furthercomprising varying, by the one or more controllers, the predeterminedpressure in accordance with a breathing cycle of the patient.
 21. Themethod of claim 16, wherein the simultaneous control of the pressure andthe flow rate of the air comprises control of a positive airway pressuretherapy and a deadspace therapy.
 22. The method of claim 21, wherein thepositive airway pressure therapy is a ventilation therapy.
 23. Themethod of claim 16 further comprising determining, by the one or morecontrollers, the predetermined pressure and the predetermined flow rateso as to restrict the predetermined pressure and the predetermined flowrate to a curve of equal efficacy.
 24. The method of claim 16, whereincontrolling the adjustable vent comprises adjusting, by the one or morecontrollers, a venting characteristic of the adjustable vent insynchrony with the patient's breathing cycle so as to maintain thepressure of the air at the patient interface to correspond with thepredetermined pressure.
 25. The method of claim 16 further comprisingadjusting, by the one or more controllers, a resistance of a variableresistance in the air circuit so as to control one or more of thepressure and the flow rate of the air.
 26. The method of claim 16further comprising calculating, in the one or more controllers, a targetventilation based on anatomical deadspace information and a deadspacetherapy reduction value.
 27. The method of claim 16 further comprisinggenerating, in the one or more controllers, a cardiac output estimate bycontrolling a step change in the predetermined flow rate of the air anddetermining a change in a measure of ventilation in relation to the stepchange.
 28. The method of claim 27 further comprising initiating, by theone or more controllers, the controlling of the step change in thepredetermined flow rate of the air in response to a detection of sleep.